Muscle optimization device and method

ABSTRACT

A system, device and method are provided for exposing a patient to therapeutic resonant frequency patterns (RFP) for therapy and treatment of a patient, for example, biological tissue such as muscle, tendon, ligament, and nerve tissue. The resonance frequencies originate from many bioactive substances, pharmaceuticals or other compounds, and key frequencies of the RFP of a compound can be replicated and then delivered to a patient using an electromagnetic catalyst to provide therapeutic benefits. RFPs can be imprinted in a separate device using a plasma imprinting device and method. This separate device can be actively excited by a delivery mechanism that uses electromagnetic or mechanical waves to interact with the device. The actively excited device transmits the RFPs or therapeutic resonant frequency patterns to the patient for similar enhancements and therapeutic benefits.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of PCT Application No.PCT/US2015/021554, filed Mar. 19, 2015; this application is acontinuation-in-part of PCT Application No. PCT/US2015/050695, filedSep. 17, 2015; this application is a continuation-in-part of U.S.application Ser. No. 14/490,378, filed Sep. 18, 2014, which is acontinuation-in-part of U.S. application Ser. No. 14/219,623, filed Mar.19, 2014, which claims the benefit of U.S. Provisional Application No.61/803,395, filed Mar. 19, 2013, all of which are incorporated herein intheir entirety by reference.

FIELD OF THE INVENTION

The present invention relates generally to the field of musclestimulation, and more particularly, to therapy and treatment of muscle,tendon, ligament, and nerve tissue by use of a device and method inwhich tissues and associated proprioceptors and neuromuscular feedbackloops are exposed to therapeutic resonant frequency patterns (RFPs),and/or the RFPs are transmitted to a patient.

BACKGROUND OF THE INVENTION

Stimulation and exercise of muscle tissue is necessary for therehabilitation and continued development of damaged and/or poorlyfunctioning muscle tissue. The failure to stimulate and exercise muscletissue inevitably results in muscle atrophy, and long periods of muscleinactivity can result in permanent damage.

There are a number of existing devices and methods that are used formuscle stimulation and rehabilitation, primarily in the field ofneuromuscular electrical stimulation (NMES). NMES is known to providemany therapeutic benefits such as prevention or retardation of disuseatrophy, pain relief, improvement of blood circulation, and others. Mostforms of electrical stimulation involve the delivery of intermittent andrepeating series of electrical pulses to the targeted muscle tissue(s).In many systems, the pulses are delivered transcutaneously by surfaceelectrodes that are placed on the patient's skin over the targetedmuscle area(s).

Included within this body of knowledge regarding NMES are a number ofpatent references. One example includes the U.S. Pat. No. 8,265,763.This reference discloses systems and methods for neuromuscularelectrical stimulation. Stimulation electrodes are provided on astimulation pad, configured to provide electrical stimulation to atargeted tissue. A system for neuromuscular electrical stimulation alsoincludes a pressure generating mechanism to provide a compressive forceto a region of the targeted tissue, thereby removing excess fluid fromthe region.

Another example of a US patent reference includes the U.S. Pat. No.8,315,711. This reference discloses a method and apparatus usingresonant pulses to treat diabetes, carpal tunnel syndrome, arthritis,and other maladies by applying a stimulating signal to promote andmanipulate blood flow. The stimulating signal may include a resonantsequence that includes at least three pulses, where the pulses of theresonant sequence are spaced relative to one another such that eachpulse subsequent to a first pulse in the sequence is effective toprogressively stimulate and create tension in a musculature thatincludes the muscle inwardly from the electrodes and towards the centerof the musculature, while maintaining the tension created in at least aportion of the musculature by each preceding pulse in the resonantsequence.

Yet another example of a US patent reference that discloses an inventionin this field is the U.S. Pat. No. 8,145,318. This reference generallydiscloses an apparatus for electrical stimulation of muscle tissue,including an electrode system with an electrode array. The array has aplurality of electrode pads and is placed in electrical contact with thetargeted muscle tissue. The electrode system further includes a sensorfor sensing a property of the muscle tissue. This property forms ameasure for the activity of the muscle tissue. The apparatus includes anelectrode selector for selecting one or more stimulating electrode pads.A signal generator is connected to the electrode array for providing anelectrical stimulation signal to the stimulation electrode pad. A signalprocessor is connected to the sensor for determining from the sensorsignal a value of the muscle activity, and outputting the value to ahuman perceptible form. This reduces the accuracy required to positionthe electrode system and increases the accuracy of measuring muscletissue activity.

Another example of a US patent reference includes the U.S. Pat. No.7,175,587. This reference discloses an apparatus and method for usingpulsed electromagnetic field (PEMF) to provide a therapeutic benefit.This reference describes inducing a magnetic field in a biologicalsystem where the pulsed electromagnetic field is used for therapeutictreatment of injury, illness, and/or aging. A straight wire elementgenerates an electromagnetic field in response to a current pulsethrough the straight wire element, and a circuit that supplies thecurrent pulse does so using a square pulse. This allows the PEMF deviceto generate an electromagnetic field with rapid rise and fall times andto provide the desired therapeutic benefit.

As further background, it is helpful to understand basic musclephysiology. Muscle fibers are activated when an alpha motor neuron(which extends from the spinal cord to the muscle) is activated. Eachalpha motor neuron activates a unique set of individual muscle fibers inwhat is called a “motor unit.” The amount of force that a muscle cangenerate is directly related to the number of motor units that areactivated. During muscle testing, if the subject can resist the amountof pressure applied, then the muscle has been activated isometricallyand no change in joint position is noted. However, if the muscle cannotresist the amount of force applied, the muscle will lengthen in what iscalled an eccentric contraction and there is a change in joint positionor angle.

Whether or not a subject can resist the pressure applied during muscletesting depends on many factors, both excitatory and inhibitory. Inother words, the level of activation of the alpha motor neuron dependson complex interactions between neurons in the spinal cord. One of themajor factors that influences alpha motor neuron activity is the effectof feedback from the muscle spindle and the Golgi Tendon Organ (GTO).The muscle spindle and GTO are sensory organs located within the muscleand tendon, respectively, and provide rich information about the lengthof the muscle and the amount of force produced by the muscle. Forexample, when a muscle is stretched, all the muscle fibers arelengthened, including the muscle spindles. The muscle spindle signalsthe change in the length of the muscle and activates the 1a sensorynerve that communicates the change to the spinal cord. The activation ofthe 1a nerve can cause activation of the alpha motor neuron of the samemuscle (the agonist), and inhibit the activation of the opposite muscle(the antagonist). Similar principles can be applied to groups ofmuscles, whether antagonistic or synergistic. The GTO registers theamount of muscle force, but may also inhibit force production if thereis a possibility of muscle damage at high forces. Inputs on the alphamotor neurons can also come from supraspinal areas of the cerebralcortex, cerebellum, or brainstem or reflexes.

Together these sensors that sense position, length, and tension ofmuscles are called “proprioceptors”. The feedback from these sensors,which are actually specialized nerve endings, goes entirely to thespinal column and subconscious parts of the brain, e.g. spinal segments,brainstem, basal ganglia, thalamus, cerebellum, etc. This provides thebody with information on the state of muscle contraction, muscle andtendon tension, position and activity of joints, and equilibrium. Whenstimulated, many of these proprioceptors adapt quickly and provideinformation on instantaneous change and rate of change in muscleactivity and body position. Others adapt only slowly to stimulation andtherefore provide steady-state information about muscle and bodyposition. Working together they provide the information necessary forcoordinated muscle action and movement and the maintenance of posture.

All muscles in the body with few exceptions are arranged in antagonisticpairs of muscles. This arrangement of muscles can be referred to asreciprocal facilitation/inhibition, because whenever one of the pair isfacilitated or turned on, its antagonist (or antagonists as there may beseveral) is automatically inhibited or turned off. Hence, the turning onand turning off are both normal states of muscle function. When a musclecontracts isometrically during muscle monitoring, signals are sent tothe “prime mover” (PM) to hold the position of the body part byconsciously facilitating the PM. Then as the pressure on the body part(e.g. an arm held horizontal) is increased during muscle monitoring, themuscle sensors (muscle spindle) in the PM respond by a spinal reflex arcreferred to as the “load reflex”. The load reflex increases the degreeof PM contraction, while at the same time inhibiting their antagonistsand facilitating their synergists. Synergists are muscles that help thePM in holding the arm up, but are not in their position of optimalmechanical advantage. Synergists contribute much less than the PM toestablishing and maintaining this position. A muscle circuit can bedefined as the PM and all other muscles, both synergists andantagonists, to which it is “wired” both at the level of the brain andspinal reflex arcs.

FIG. 1 provides an example of a simplified muscle circuit. Morespecifically with respect to a muscle circuit, each muscle in the bodyhas antagonists (usually more than one) that oppose its action. Theagonist or PM and its antagonist(s) are neurologically wired togethervia the spindle cells in the belly of these muscles. This neurologicalwiring is such that when a PM is facilitated (turned on) it sendssignals to automatically inhibit (turn off) its antagonist(s) to thesame degree it has been facilitated. At the same time, if the load issufficiently large it facilitates its synergists. In this way, the limbmoves in the direction of contraction, unopposed by its antagonist(s),permitting smooth and rapid movement of the limb. Likewise, facilitationof an antagonist will inhibit the PM, as the spindle cells of theantagonist(s) need to inhibit the PM in order to move the limb in theopposite direction from the action of the PM. Referring to FIG. 1, itillustrates a muscle circuit consisting of an agonist or prime mover(biceps), one antagonist (triceps) and one synergist (brachioradialis).The spindle cell of the PM is wired to both its antagonist, which itinhibits, and its synergist, which it facilitates. Not shown is thereciprocal spindle cell circuitry for the antagonist, the triceps. Whenthe triceps is facilitated, spindle cells in the belly of the tricepssend signals to inhibit the biceps and its synergists thebrachioradialis.

During a series of muscle contractions and relaxations, information onthis series of activity is also sent to subconscious parts of the brain,e.g. the basal ganglia and thalamus, which control “pre-recorded” muscleprograms, and the cerebellum where comparisons are made of intendedactions and actual actions. If an intended action is to keep the armheld at horizontal, but the arm moves downward due to the increasingpressure of a dynamic load, the subconscious brain centers augment theautomatic spinal load reflex and orders additional contraction of the PMto offset movement, thereby helping the arm to remain horizontal. Aslong as the flow of information from muscle sensors to and from thebrain remains “clear” with no interruptions, the muscle can maintain theisometric contraction until the muscle reaches its full power ofcontraction. If loading continues above this point, the arm will movedown as the PM is overpowered by the downward pressure of the dynamicload, resulting in an eccentric contraction.

During muscle testing, the pressure applied is far less force thanneeded to overpower the PM. A muscle with full neurological integrityshould therefore maintain the isometric contraction during musclemonitoring. That is, unless something interferes with the neurologicalflow of information between the muscle and the central nervous system,the muscle should be facilitated sufficiently to maintain its physicalposition even under increasing load. This capability of the muscle tomaintain an isometric contraction indicates a muscle that can beconsidered in “balance” with its neurological circuitry. If there isinterference or a disruption in the flow of information between a muscleand the central nervous system, the muscle will not be able tocoordinate and match its degree of facilitation to the increasingloading taking place during muscle testing/monitoring. Accordingly, thearm will move downward appearing to fail under the monitoring pressure,resulting in an eccentric contraction. A muscle that fails to maintainthe isometric contraction such as by inhibited feedback from musclespindle cells, tendon and joint sensors or inhibitory feedback fromsubconscious emotional brain centers, can be described as being“under-facilitated” relative to the pressure being applied. Theeccentric contraction of the muscle may be observed simply as the musclebeing weak (i.e. failing under the monitoring pressure). However, themuscle is not weak, but rather inhibited or under-facilitated to resistthe monitoring pressure.

For muscles to function properly, they require a number of differentnutrients, including vitamins, minerals, and trace elements insufficient concentrations to maintain the required energy production formuscle function. Muscle tissue also requires a variety of amino acidsfor structural integrity and repair, and to provide energy for propermuscle function. When any of the components of this nutritional formulais deficient, it may reduce the effectiveness of muscle function.Additionally, the proper ratios and concentrations of the nutrientswithin this formula are necessary for maintenance of on-going musclefunction. One of the problems of aging is a decrease in theeffectiveness with which the body both assimilates and utilizesnutrients and thus muscle function is often affected by these nutrientimbalances due to these natural processes.

While there may be a tremendous amount of information availableregarding traditional techniques and therapies for improving musclefunction, the great majority of this information relates to electricalor chemical methods of treatment. Muscle stimulation by NMES has provento provide certain benefits. Providing a patient with an improved dietand/or supplementation of vitamins, minerals, and other nutrients thatwere shown to be lacking has also proven to provide certain benefits.

However, nutritional supplementation, stimulation and exercise alone areoften not enough to strengthen “weak” muscles due to inhibition of themuscle via muscle spindle cell, Golgi tendon organ and Golgi ligamentorgan receptors whose job it is to “protect” the structural integrity ofthe muscle and its related tendons and ligaments should tension on themuscle exceed a threshold level. Often injury or even simply slipping oran unusual activity can “unset” this threshold for inhibition such thatthe Spindle cell, Golgi tendon organ or Golgi ligament organ receptorsnow inhibit the muscle action long before there is any likelihood ofdamage to the muscle, tendon or ligament. Thus, when the person nowtries to use this muscle it appears “weak” as it just cannot developmuch power.

A muscle in this “inhibited” state responds very poorly to normalrehabilitation even using the electrical stimulating devices becauseaccording to Wolf's Law in physiology, in order to build more strength,and muscle must develop more tension. This is because tension is thesignal for the muscle to make more muscle fibers, which is whatincreases its strength. If, however, the muscle is inhibited at aspecific level of tension (even one that does not approach tension thatwould be harmful) by the “unset” Spindle cell, Golgi tendon or Golgiligament organ receptors, this inhibition prevents the development offurther tension, and thus the muscle is not given the signal to makemore muscle fibers. Muscles inhibited in this way, even when exercisedregularly can never get stronger, and thus present as chronic muscleproblems. Until the “unset” receptors are “reset”, this problem willpersist.

Thus, traditional techniques and therapies for improving muscle functionstill may not provide optimal results for many patients that havecertain imbalances or maladies manifesting in poor muscle function. Inaddition, traditional delivery platforms for medical treatments such ashypodermic injections, oral ingestion, or dermal patches haveshortcomings. Namely, traditional delivery platforms are indiscriminateand result in many negative side effects. Therefore, there is still aneed to provide an alternative form of treatment and delivery platformthat does not rely upon traditional techniques/therapies.

SUMMARY OF THE INVENTION

In accordance with the present invention, a device and method areprovided that expose a patient to therapeutic resonant frequencypatterns (RFP). This delivery platform addresses shortcomings oftraditional delivery platforms such as negative side effects, andtherapeutic RFPs can be used for therapy and treatment of biologicaltissue such as muscle, tendon, ligament, and nerve tissue. In additionto musculature treatments, a device and method are provided that canexpose all or portions of the body to compounds to induce a responsefrom the body. Disease states that may be treated or ameliorated usingthe devices and methods of the present invention include multiplesclerosis, Parkinson's disease, cerebral palsy, amyotrophic lateralsclerosis (Lou Gehrig's Disease, ALS), muscular dystrophy, myotonicdystrophy, and Graves' disease, spinal-bulbar muscular atrophy,myasthenia gravis, Huntington's Disease, polymyositis, Lambert-Eatonsyndrome, monomelic amyotrophy, progressive bulbar palsy, lower motorneuron weakness, upper motor neuron weakness, peripheral neuropathy,diabetic peripheral neuropathy, spinal cord injuries, botulism, GuillainBarre syndrome, and Pompe disease. Devices and methods of the presentinvention may also be used in coordination with rehabilitation, physicaland occupational therapy, osteopathic and chiropractic treatment, andsports training.

According to the present invention, it may be considered a device andmethod in which tissues and associated proprioceptors and neuromuscularfeedback loops are exposed to therapeutic RFPs and/or therapeutic RFPsare transmitted to, or interact with, a patient, in which the RFPsoriginate from many types of bioactive substances or domains, includingvitamins, minerals, herbs, amino acids, proteins, nucleic acids, fattyacids, nutritional supplements, and pharmaceutical compounds. Theparticular combination of the bioactive substances or domains used inthe present invention is designed to achieve a specific effect and maybe referred to as a “muscle formula”, a “hypoxic formula”, or any otherformula as explained further below. Each formula includes nuclearmagnetic resonance (NMR) spectrum or infrared vibrational (IV) spectrumbased on, for example, the physical properties of constituentsubstances. These frequency-based properties as transferred to thedevice of the invention are artifacts of the formula, and can bereferred to as RFPs.

The RFPs of a formula are identified, captured, and ultimately deliveredor transferred to a device or patient. To identify the RFPs of a formulathrough IV spectrum, an infrared spectrometer such as a Fouriertransform infrared spectrometer outputs a series of absorption lines asa function of the wavenumber, which is proportional to the inverse ofthe wavelength. The largest absorption lines correspond to thecharacteristic vibration modes of atoms with the formula of interest.The most significant of these absorption lines are chosen by a standard(e.g., the largest two to five absorption lines), then an arbitrarywaveform generator can reproduce the absorption lines to replicate keyfrequencies of the RFP of the formula. The NMR of a formula may besimilarly utilized to replicate key frequencies of the RFP of a formula.See Verginadis, I. I., Simos, Y. V., Velalopoulou, A. P., Vadalouca, A.N., Kalfakakou, V. P., Karkabounas, S. C. & Evangelou, A. M., Analgesiceffect of the electromagnetic resonant frequencies derived from the NMRspectrum of morphine, Electromagnetic Biology and Medicine, 31(4):275-284, 2012. The replicated key frequencies of the RFP of a formulahave been applied to chemical systems as described in U.S. Pat. No.6,033,531; US Publication No. 2011/0073462; and US Publication No.2002/0031814.

The process or means by which the NMR spectrum are delivered ortransferred to a device or patient can be described as methods oftransfer by imprinting, infusing, entraining, or imaging. As usedhereinafter, the terms “transfer”, “imprint” or “imprinted” as usedhereinafter can describe the each or selected ones of these methods oftransfer and/or the physical state of the device of the invention aftertransfer of the RFPs. The imprint of the RFPs is a durable and lastingcondition for the device that may last months or even years.

The targeted muscle or tissue of a patient has various ways to receiveRFPs delivered from a device. All molecules, includingbiologically-active molecules, store energy in a wide range of modes(including electronic, vibrational, rotational, and nuclear magneticenergy states), and exchange it with the environment via resonantfrequencies spanning a correspondingly large range of theelectromagnetic spectrum (from ultraviolet, visible and infrared lightthrough microwaves, radio waves, and possibly even extremely lowfrequencies). Energy exchanged via higher-energy interactions istypically quickly dispersed in dense media as heat, though metastablelow-energy states can persist for extended periods of time. There isevidence that cellular chemistry and intra- and inter-cellularcommunication and signaling can be affected by electromagnetic stimuliin these energy regimes.

According to one theory, the human body may respond directly to thefrequencies or molecular resonance of bioactive substances including,but not limited to, nutrients, hormones, neurotransmitters,neuropeptides, and cytokines. Such a response might be mediated bysympathetic resonance, which does not require actual contact of thesubstances with the body. An analogy is the tuning-fork effect, in whicha first tuning fork, vibrating at its resonance frequency, will causeanother tuning fork of the same frequency to vibrate at the samefrequency, even though there is no direct physical contact between thetuning forks (in this case, in air, the resonance is mediated bypressure waves in the acoustic medium). Via a corresponding phenomenon,molecular resonance might transfer energy between similar molecules orsimilar molecular subunits, even when they are not touching. The mannerin which resonant frequencies mediate interactions among nutrients andother molecules within the body is a topic of current research.

A recent study conducted in the United Kingdom involved research on howmolecules interact via their emitted or radiated frequencies. This studyevolved from successful treatments of people with electromagneticsensitivity. In the study, clinical data supported a conclusion that achemical in a sealed vial or ampoule can trigger an allergic reaction,for example, without the substance being introduced into the patient'sbody or touching their body. Thus, a reasonable mechanism to explainthese phenomena is that the molecules in the sealed vial when placednear the body transmit their specific frequencies to the body via theweak electromagnetic fields that they emit, which in turn interacts withthe resonance frequencies of molecules within the body. See Choy, R. V.S., Monro, J. A. and Smith, C. W., Electrical Sensitivities in AllergyPatients; Clinical Ecology 4(3): 93-102, 1987; see also Smith, C. W.,Electromagnetic Effects in Humans; In Biological Coherence and Responseto External Stimuli, Herbert. Froelich (ed.) Springer-Verlag, Berlin,pp. 205-232, 1988.

Another study examined the effect of exposure of rats to electromagneticwaves related to the RFP of morphine. Rats exposed to theseelectromagnetic waves showed decreased nocioception (sensitivity to painstimuli) compared to rats exposed to nonspecific frequencies, ratsexposed both to morphine-specific frequencies and a morphine suppressor,and a control group, though the decrease was not as great as for ratstreated with morphine by injection. See Verginadis, I. I. et al.

In summary, the frequencies radiated by the molecules as well as thechemicals themselves can disrupt regulatory systems, or restore thesesystems to normal operation. These phenomena fall into the category ofexternal or exogenous homeopathy in which the remedy does not touch thebody, yet produce a specific physiological effect, e.g. an allergicreaction, or the elimination of an allergic reaction. This provides amodel for how the RFPs of the nutrients in the muscle formula may betransmitted to the tissues of the muscles, tendons, ligaments, andnerves, and that this exposure can bring the muscle back into normalfunction, even when the device of the present invention is notphysically touching the body or placed directly on the muscle beingtreated.

Some embodiments the present invention incorporate a device or substrateof a suitable material upon which the therapeutic RFPs of a formula areimprinted. Suitable materials include, but are not limited to, glasses,ceramics, minerals, plastics, semiconductors, and piezoelectricmaterials, in pure, mixed and doped forms, with crystalline,polycrystalline, glassy, amorphous, or sintered structure.

Similarly, in another preferred embodiment, an imprinted material may beapplied to or embedded within a device. The material may include aliquid, gel, or slurry containing a formula mixed with an adhesive glue.As mentioned, the formula may include, but is not limited to, sodium,magnesium, calcium, potassium, boron, chloride, sulphate, bicarbonate,alumina, and silica, and combinations thereof. The material is mixedwith adhesive glue that may be applied to the device.

Also in accordance with the preferred embodiment, the RFPs of a formulamay be embedded within the device. First, the formula is prepared bygrinding and mixing the constituent components of the formula. Listedbelow are chemicals/compounds/plant types that may be used within theformula. These chemicals/compounds/plant types may be used in differentquantities and/or concentrations within the formula to achieve specificobjectives for the treatment to be conducted. Although a specificlisting of components is provided, it should be understood that theformula can incorporate a host of other components, and therefore thislisting should not be considered as exclusive. These components mayinclude:

L-Phenylalanine Choline L-Glutamine Lecithin L-Carnitine Calciumgluconate L-Taurine Magnesium stearate or gluconate Betatene or othermixed Silica carotenoids Iron gluconate, picolinate or Magnesiumstearate or gluconate glycinate Lemon or citrus bioflavonoids Zincgluconate or picolinate Lithium Manganese gluconate Thiamine (VitaminB1) Chromium sulphate or picolinate Riboflavin (Vitamin B2) Potassiumiodide Nicotinamide (Vitamin B3) Minerals Calcium pantothenate D-Ribose(Vitamin B5) Hyaluronic acid Pyridoxine (Vitamin B6) Chondroitinsulphate Methylcobalamin (Vitamin B12) Glycosylated glucosamine Folicacid or L-Methylfolate Collagen Biotin Creatine monohydrate Ascorbicacid (Vitamin C) Kelp Rosehips Alfalfa, Vitamin D White Willow BarkExtract, Vitamin E (preferably, d-alpha) and combinations of theseInositol components.

The lithium may include organic sources of lithium, such as lithiumfound in brewer's yeast (Saccharomyces cerevisiae), or lithium inmineral form (e.g. lithium orotate).

The D vitamin may be supplied as vitamin D3 (cholecalciferol) and/orvitamin D2 (ergocalciferol).

The minerals may include any elements selected from: Ag, Al, As, Au, B,Ba, Be, Bi, Br, C, Ca, Cd, Ce, Cl, Co, Cr, Cs, Dy, Er, Eu, F, Fe, Ga,Gd, Ge, H, Hf, Hg, Ho, I, In, Ir, K, La, Li, Lu, Mg, Mn, Mo, N, Na, Nb,Nd, Ni, O, Os, P, Pb, Pd, Pr, Pt, Re, Rh, Ru, S, Sb, Sc, Se, Si, Sm, Sn,Sr, Ta, Tb, Te, Th, Ti, Tl, Tm, V, W, Y, Yb, Zn, and Zr. Preferably,these minerals are used or added to other components of the muscleformula as a colloidal suspension.

Lemon bioflavonoids are anthoxanthins (flavones and flavonols) that mayinclude isoflavonoids derived from 3-phenylchromen-4-one(3-phenyl-1,4-benzopyrone) and neoflavonoids, derived from4-phenylcoumarine (4-phenyl-1,2-benzopyrone). The collagen proteins maybe type I or type II, or a combination thereof. Alfalfa, also calledlucerne, may include flowering plants in the pea family Fabaceae. Kelpsinclude any genera of brown algae, Phaeophyceae, in the orderLaminariales.

Another embodiment of the invention is a composition comprising at leasttwo components making up the muscle formula, including L-phenylalanine,L-glutamine, L-carnitine, L-taurine, betatene, lemon bioflavonoids,lithium, thiamine (vitamin B1), riboflavin (vitamin B2), nicotinamide(vitamin B3), calcium pantothenate (vitamin B5), pyridoxine (vitaminB6), methylcobalamin (vitamin B12), folic acid, biotin, ascorbic acid(vitamin C), rosehips, vitamin D, vitamin E (preferably, d-alpha),inositol, choline, lecithin, calcium gluconate, magnesium stearate,silica, iron gluconate, zinc gluconate, manganese gluconate, chromiumsulphate, potassium iodide, minerals, D-ribose, hyaluronic acid,chondroitin sulphate, glycosylated glucosamine, collagen, creatinemonohydrate, kelp, alfalfa and combinations of these components. Thesecompositions may be dissolved or suspended in an alcohol, such as anaqueous alcohol solution. In certain embodiments, the alcohol of thesecompositions is ethanol.

After preparation of the formula, the therapeutic RFPs of the formulacan be imprinted on the device by one of several methods as describedbelow. In many cases, the mixture is first prepared for imprinting bydissolution in an aqueous ethanol solution. In an exemplary method, asample of the aqueous alcohol/solution is placed into a quartz chamber.The sample might contain 5-500 ml of the solution. The quartz chambercontaining the solution is placed into an apparatus in which themagnetic field generated by a pulsed electromagnetic field (PEMF) devicepasses through the quartz chamber, to illuminate a target device. ThePEMF is activated, and the target exposed for a period of time; thetime-varying magnetic field serves as a carrier wave to transfer theRFPs of the formula to the device. The RFPs has been shown to beretained or imprinted on the device.

The foregoing describes some embodiments by which therapeutic RFPs canbe imprinted within a suitable material or device. The present inventionencompasses other devices capable of retaining such imprints, and othermethods of imposing the imprinted pattern. Other imprintable materialsinclude materials such as glasses, ceramics, minerals, plastics,semiconductors, piezoelectric materials, gels and viscous materials, inpure, mixed and doped forms, with or without an associated or embeddedformula, with or without surface treatments, and having crystalline,polycrystalline, glassy or amorphous structure. Other methods ofimposing or imprinting a therapeutic RFP include techniques based onmechanical, acoustic or electromagnetic waves, and plasma generationsystems, and any combination of individual techniques.

According to the method of the present invention, the RFPs of theformula can be delivered to the body in many ways, including passive oractive excitement of an imprinted device. According to a first method,the imprinted device may be applied directly to the body for a period oftime, while the person performs certain activities that activatespecific muscles involved in different patterns of motor activity,thereby re-integrating muscle dysfunction. According to this method, thedevice may be applied directly over the targeted group of muscles to betreated, and then directed exercises are performed to achieve thetherapeutic effect. For example, this direct application method can beachieved by placing the device on the skin over the affected muscle(such as a bicep muscle), and then the bicep muscle is taken throughthree series of contractions. The targeted muscle(s) are then directedto be held in their most contracted position for approximately 5 secondswhile a load is applied to the body part that is supported by thetargeted muscle(s). The targeted muscle(s) are then relaxed for a periodof approximately 30 seconds, and the targeted muscle(s) is then directedto be isometrically contracted or locked for approximately another 5seconds, while increasing pressure is applied against the isometricallycontracted or locked muscle. The cycle may be repeated a third time.Through Electromyographic (EMG) testing (described below), it has beenshown that this method can reset muscle proprioception. After a periodof approximately 2 minutes, the integrity of muscle function can bere-checked to confirm that the muscle proprioception has been reset. Ifsuccessful, the targeted muscle(s) should now isometrically contract orlock strongly against monitoring pressure, yet should be able to besedated using spindle cell, golgi tendon organ and golgi ligament organssedation techniques.

The RFP of the imprinted device may also be actively excited. Forexample, a device imprinted with the RFPs of a formula may be placedproximate to a muscle or muscle group of a patient. The imprinted deviceis excited to transmit the RFPs of the formula from the imprinted deviceto the muscle. Thus, for example, if the formula includes variouspharmaceutical compounds, then the muscle produces a response as if themuscle were physically receiving the various pharmaceutical compounds byone or more conventional methods. This induced response provides atangible and measurable therapeutic benefit to the patient that does notrequire the physical application or ingestion of a substance in thepatient's body. Further, an imprinted device is or may be reusable,which may greatly reduce costs of treatment. In one preferredembodiment, the affected tissue is exposed to the magnetic field outputof a PEMF device which first passes through an imprinted device. Theaffected muscle is taken through three cycles of contraction asdescribed above to reset proprioception.

For example, in some embodiments the device is a piezoelectric crystaland the delivery mechanism imposes an electric field on the crystalwhich causes the crystal to change shape. When the delivery mechanismceases to impose an electric field, the crystal reverts back to itsoriginal size and shape, and the crystal emits a resonance frequency.This resonance frequency and harmonics thereof may then be implementedto a user for therapeutic benefit. In embodiments of the presentinvention, the resonance frequency of a particular device may depend onits physical attributes. For example, the size of the device influencesthe resonance frequency. In crystals such as quartz, how the crystal iscut influences the resonance frequency. In an “AT” type of crystal cut,the crystal's x axis is inclined by approximately 35° relative to the zaxis. This cut results in a crystal that is less sensitive tofluctuations in temperature. Additionally, the material that the layeris comprised from influences the resonance frequency.

According to the theory supporting the therapeutic benefits of thepresent invention, muscle imbalance or dysfunction can be caused by thelack of or incoherence of certain frequencies needed to maintain normalfunction. Direct activation or dynamic muscle activity exposes themuscle imbalance to therapeutic intervention. The device imposes aharmonic resonance field to the muscle imbalance. Thus, the affectedmuscle can be brought back into normal function by transferring the RFPretained in the imprinted device to the muscle, thereby resetting musclefunction.

Treatment by use of the invention can be enhanced if the caregiver has aworking knowledge of muscle function, including how to position musclesfor proper muscle monitoring. Treatment can be further enhanced if thecaregiver has a working knowledge of muscle monitoring or muscle testingtechniques.

The device and method of the present invention can rapidly reset muscleproprioception to restore normal muscle function, often resolving evenlong-term chronic pain and dysfunction. The device and method mayfurther reduce days of stay in a hospital, reduce rehabilitation times,reduce need for many operations, and save the hospital and insurancesystems time and resources, as well as to save patients out of pocketcosts. This invention is also non-invasive with only minimalside-effects. Through IRB-approved university research, it has beenfound that muscle improvement can take place, often within seconds up toa period of 30 minutes, and these benefits appear to be long-lasting.Therefore, embodiments of the present invention may serve as a deliverymechanism for medicine, just as capsules, syringes, IV drips, and dermalpatches deliver medicine.

In view of the disclosures herein a series of five exemplary embodimentsof the present invention are provided. In a first exemplary embodiment,replicated key frequencies of the RFP of a formula are imprinted ortransferred to a device, or a neutral medium such as silicon, which isthen positioned on or near a patient. A series of testing steps can beadministered to discern the state of a portion of the body. Then, aseries of therapeutic steps can be performed on the patient with theimprinted device located on or near the target portion of the body. Thedevice catalyzes the patient's response to a PEMF therapy and enables orenhances the response. It will be appreciated that any electromagnetictherapy can be used in embodiments of the invention.

The RFP of the formula sample can be identified by a nuclear magneticresonance spectrum of the formula sample where the nuclear magneticresonance spectrum has a plurality of local peaks, and at least one ofthe local peaks is selected to replicate key frequencies of the RFP ofthe formula sample. Alternatively, the RFP of the formula sample can beidentified by an infrared vibrational spectrum of the formula samplewhere the infrared vibrational spectrum has a plurality of local peaks,and at least one of the local peaks is selected and frequency-shifteddown to a frequency with harmonics at the infrared frequency toreplicate key frequencies of the RFP of the formula sample. The combinedelectronic signal delivered by a transmitter can comprise a waveform,wherein the waveform is one or more of a square wave, a pulse wave, anda sawtooth wave.

In a second exemplary embodiment, a method of delivering replicated keyfrequencies of a RFP and a pulsed electromagnetic field frequency isprovided to a patient. In this embodiment, the physical catalyst inreplaced with an electromagnetic catalyst, which has multiple benefits.For instance, an electromagnetic catalyst does not wear out over timelike a physical catalyst. In addition, the frequencies of anelectromagnetic catalyst can easily be changed, and thus, multiplecatalysts can be used in a session in a preprogrammed fashion. Furtherstill, an electromagnetic catalyst and a PEMF device can applyelectromagnetic frequencies to a common area on the patient since, insome embodiments, the frequencies of the electromagnetic catalyst andthe PEMF device are emanated from the same source. This improves theeffectiveness of the treatment in patients.

In practice, a formula sample having a RFP is provided, and the RFP isidentified so that key frequencies of the RFP can be replicated. Thesereplicated key frequencies of RFP of the formula sample are combinedwith a pulsed electromagnetic field frequency into a combined or mixedelectronic signal. A transmitter such as a diode, coil, or antenna emitsthe combined electronic signal to an area of a patient to catalyze aresponse from the patient.

Frequencies can be combined or mixed by applying a voltage or currentcontaining multiple frequencies to a nonlinear element, such as a diode.The diode output contains the original frequencies as well as sum anddifference frequencies of the original frequencies. Alternatively,multiple sets of frequencies, for example catalyst and PEMF frequencies,can simply be applied simultaneously through a single coil or antenna.

In a third exemplary embodiment, another method of delivering replicatedkey frequencies of a RFP and a pulsed electromagnetic field frequency isprovided to a patient, except that the two frequencies are provided byseparate sources. A formula sample having a RFP is provided, and the RFPis identified so that key frequencies of the RFP can be replicated. Afirst arbitrary waveform generator is provided to generate keyfrequencies of the RFP and deliver these frequencies via a transmitterto a portion of the patient. A second arbitrary waveform generator isprovided to generate a pulsed electromagnetic field frequency anddeliver these frequencies via a transmitter to the same or differentportion of the patient. In some embodiments, key frequencies of thereplicated RFP of the formula sample and the pulsed electromagneticfield frequency are simultaneously delivered to the patient, and theaddition of the key frequencies of a RFP to the pulsed electromagneticfield frequency serves to catalyze a patient's response to the PEMFtherapy and enables or enhances the response.

It will be appreciated that the catalyzing effect can be used with awide range of other electromagnetic therapies, such as transcranialdirect current stimulation (tDCS). A further application of theinvention is to enhance the effectiveness of non-electromagnetictherapies, including pharmaceuticals, physical and chiropractic therapy,homeopathy, acupuncture, psychological counseling, and traditionalapproaches such as Qigong and Ayurvedic medicine.

In a fourth exemplary embodiment, a device is imprinted with keyfrequencies of a RFP of a formula sample by a plasma generator andprocess, then the device is used to catalyze a patient's response to aPEMF treatment. The plasma generator may comprise a vessel that definesan enclosed volume where the enclosed volume has a first end and asecond end. The enclosed volume has a formula area positioned betweenthe first end and the second end. An inert gas source is operablyinterconnected to the first end of the enclosed volume of the vessel,and a pump is operably interconnected to the second end of the enclosedvolume of the vessel. Examples of inert gases include helium, neon,argon, krypton, xenon, and radon. It will be appreciated that many othergases, and/or combinations of gases, may be used in embodiments of theinvention including non-oxidizing gases, oxygen, hydrogen, nitrogen,etc. An electromagnetic field generator having a coil with at least oneturn positioned about the formula area of the enclosed volume. A formulasample is at least partially provided in the formula area of theenclosed volume, and the device to be imprinted is positioned betweenthe formula area and the second end of the enclosed volume. The pumpdraws air out of the enclosed volume until a pressure in the enclosedvolume is below a first predetermined threshold. Then, the inert gassource releases inert gas into the enclosed volume until the pressure inthe enclosed volume rises from below the first predetermined thresholdto above a second predetermined threshold. The electromagnetic fieldgenerator and coil generate an electromagnetic field to strike the inertgas in the enclosed volume and produce a plasma, which imprints a RFP ofthe formula sample to the device.

In various embodiments, the first predetermined threshold isapproximately 115 mTorr, and the second predetermined threshold isapproximately 170 mTorr. In some embodiments, the inert gas is argon,and the device is a doped glass. It will be appreciated that the glassmay be doped with, for example, chromium, neodymium, erbium, thulium,ytterbium, and/or other materials. It will be further appreciated thatpiezoelectric materials can be used in addition or in place of dopedglass, as it is described herein.

In various embodiments, the electromagnetic field is activated for 15minutes, the electromagnetic field generator generates theelectromagnetic field using an electronic signal having a frequency of13.56 MHz, and the electronic signal produced by the function generatoris a waveform, wherein the waveform is one or more of a square wave, apulse wave, and a sawtooth wave. The electromagnetic field generator maycomprise multiple components. For instance, the electromagnetic fieldgenerator may comprise a function generator and an amplifier that hasthe coil with at least one turn positioned about the formula area of theenclosed volume, wherein the function generator is configured totransmit an electronic signal to the amplifier at a first voltage, andthe amplifier outputs the electronic signal to the coil at a secondvoltage, wherein the second voltage is larger than the first voltage. Inaddition, the electromagnetic field generator may comprise an impedancematcher that is operably connected to the function generator and theamplifier, wherein the impedance matcher matches an impedance of thefunction generator and an impedance of the amplifier. As with otherembodiments, the imprinted device is placed proximate to a patient andused in combination with other frequencies generated by, for example, aPEMF device to catalyze a patient's response to the PEMF treatment.

In a fifth exemplary embodiment, a device is imprinted by the plasmagenerator and process described herein. However, in contrast to thefourth embodiment described above, the fifth exemplary embodimentutilizes an additional device and method to actively excite theimprinted device. A delivery mechanism may produce two types of waves toexcite the device: electromagnetic waves and mechanical waves such asacoustic waves. These waves interact with attributes of the device suchthat the device produces the RFP.

A further application of the invention is to enhance the effectivenessof therapeutic activities, such as exercise, meditation, tai chi, andsports practice. A further application of the invention is to enhancethe effectiveness of mental activities, such as studying, practicingmusic playing, and carrying out presentations.

It will be appreciated that wherever a PEMF is used, other radiantsources may be substituted for it, such as a laser, or a continuouselectromagnetic source. Similarly, the NMR spectrum may be replaced byany other spectrum that identifies key electromagnetic or vibrationalsignatures of the substance. For example, the infrared vibrationalspectrum may be used instead. The type of spectrum used will dictate themethod used to replicate the key frequencies during therapy. While anarbitrary waveform generator that drives an antenna or coil can be usedwith the NMR signals, single or multiple laser lines may be used toreproduce the key frequencies in an infrared vibrational spectrum thatare frequency-shifted down to a frequency with harmonics at the infraredfrequencies. When a nutraceutical is described, it may be replaced byone or a combination of the multiple other materials listed in theearlier patent application.

In the cases where a coil is used, it is generally meant to be astandard coil consisting of wire wrapped in a single direction.Alternatively, a caduceus coil may be utilized, which is wound in bothdirections. A caduceus coil does not produce a conventional magneticfield, but rather a reduced magnetic field relative to a standard PEMFfield, and some patients find such PEMF magnetic fields to beobjectionable or even harmful in the case of electronic implants.

One specific embodiment of the invention is a method of deliveringreplicated key frequencies of a resonant frequency pattern anddelivering a pulsed electromagnetic field frequency to a patient,comprising (i) providing a formula sample having a resonant frequencypattern; (ii) identifying a frequency-based characteristic of theresonant frequency pattern of the formula sample; (iii) selecting aplurality of key frequencies from the frequency-based characteristic ofthe resonant frequency pattern for replication; (iv) providing anarbitrary waveform generator, a nonlinear element, and a transmitter;(v) generating, by the arbitrary waveform generator, the replicated keyfrequencies of the resonant frequency pattern of the formula sample;(vi) combining, by the nonlinear element, the replicated key frequenciesof the resonant frequency pattern of the formula sample and a pulsedelectromagnetic field frequency into a mixed electronic signal; and(vii) delivering, by the transmitter, the mixed electronic signal to apatient.

In some embodiments, the frequency-based characteristic of the resonantfrequency pattern of the formula sample is a nuclear magnetic resonancespectrum of the formula sample, wherein the nuclear magnetic resonancespectrum has a plurality of local peaks, and at least one of the localpeaks are selected as key frequencies of the resonant frequency patternof the formula sample. In various embodiments, the frequency-basedcharacteristic of the resonant frequency pattern of the formula sampleis an infrared vibrational spectrum of the formula sample, wherein theinfrared vibrational spectrum has a plurality of local peaks that havebeen frequency-shifted down to frequencies with harmonics at theinfrared frequencies, and at least one of the local peaks are selectedas key frequencies of the resonant frequency pattern of the formulasample.

In certain embodiments, the mixed electronic signal combined by thenonlinear element comprises a waveform, wherein the waveform is one ormore of a square wave, a pulse wave, and a sawtooth wave. In furtherembodiments, the nonlinear element is a diode configured to combine thekey frequencies and the sum and difference frequencies of the keyfrequencies with the pulsed electromagnetic field frequency into themixed electronic signal. In various embodiments, a pulsedelectromagnetic field device comprises the arbitrary waveform generatorand the nonlinear element, and the mixed electronic signal is a pulsedelectromagnetic field output that is modulated by the replicated keyfrequencies of the resonant frequency pattern of the formula sample.

Another particular embodiment of the invention is a method of deliveringreplicated key frequencies of a resonant frequency pattern to a patientto catalyze a response of the patient to a therapy, comprising (viii)providing a formula sample having a resonant frequency pattern; (ix)identifying a frequency-based characteristic of the resonant frequencypattern of the formula sample; (x) selecting a plurality of keyfrequencies from the frequency-based characteristic of the resonantfrequency pattern for replication; (xi) providing an arbitrary waveformgenerator and a transmitter; (xii) delivering, by the transmitter, thereplicated key frequencies of the resonant frequency pattern of theformula sample that are generated by the arbitrary waveform generator toa patient; and (xiii) applying a therapy to the patient, wherein thedelivery of the replicated key frequencies of the formula sample to thepatient catalyzes the response of the patient to the therapy.

In various embodiments, the frequency-based characteristic of theresonant frequency pattern of the formula sample is a nuclear magneticresonance spectrum of the formula sample, wherein the nuclear magneticresonance spectrum has a plurality of local peaks, and at least one ofthe local peaks are selected as key frequencies of the resonantfrequency pattern of the formula sample. In some embodiments, thefrequency-based characteristic of the resonant frequency pattern of theformula sample is an infrared vibrational spectrum of the formula samplethat has been frequency-shifted down to frequencies with harmonics atthe infrared frequencies, wherein the infrared vibrational spectrum hasa plurality of local peaks, and at least one of the local peaks areselected as key frequencies of the resonant frequency pattern of theformula sample.

In certain embodiments, the replicated key frequencies of the resonantfrequency pattern of the formula sample generated by the arbitrarywaveform generator comprise a waveform, wherein the waveform is one ormore of a square wave, a pulse wave, and a sawtooth wave. In additionalembodiments, the formula sample is a composite formula that comprises atleast one resonant frequency pattern from at least one of anutraceutical formula, an oxygen formula, and a hypoxic formula.

In some embodiments, the therapy applied to the patient is anelectromagnetic therapy, which has a pulsed electromagnetic field devicethat delivers a pulsed electromagnetic field to the patient, and thepulsed electromagnetic field and the replicated key frequencies of theformula sample are simultaneously delivered to the patient. In variousembodiments, the therapy applied to the patient is a non-electromagnetictherapy, which is one of a pharmaceutical compound, a physical andchiropractic therapy, a homeopathy therapy, an acupuncture therapy,psychological counseling, Qigong medicine, and Ayurvedic medicine. Incertain embodiments, the therapy applied to the patient is anon-electromagnetic therapy, comprising (xiv) positioning a muscletissue of the patient having a potential imbalance in a state ofcontraction; (xv) confirming an indicator change in the muscle; (xvi)delivering the replicated key frequencies to the patient; (xvii) againplacing the muscle in a state of contraction; (xviii) applying pressureto the muscle; and (xix) retesting the muscle to confirm a therapeuticeffect has been achieved.

Yet another particular embodiment of the invention is a method ofdelivering replicated key frequencies of a resonant frequency pattern toa patient to catalyze a response of the patient to a therapy, comprising(xx) providing a formula sample having a resonant frequency pattern;(xxi) identifying a frequency-based characteristic of the resonantfrequency pattern of the formula sample; (xxii) selecting a plurality ofkey frequencies from the frequency-based characteristic of the resonantfrequency pattern for replication; (xxiii) imprinting a device with thereplicated key frequencies of the resonant frequency pattern of theformula sample; (xxiv) placing the imprinted device proximate to apatient; and (xxv) applying a therapy to the patient, wherein thereplicated key frequencies of the formula sample from the imprinteddevice catalyzes the response of the patient to the therapy.

In some embodiments, the frequency-based characteristic of the resonantfrequency pattern of the formula sample is a nuclear magnetic resonancespectrum of the formula sample, wherein the nuclear magnetic resonancespectrum has a plurality of local peaks, and at least one of the localpeaks are selected as key frequencies of the resonant frequency patternof the formula sample. In various embodiments, the frequency-basedcharacteristic of the resonant frequency pattern of the formula sampleis an infrared vibrational spectrum of the formula sample, wherein theinfrared vibrational spectrum has a plurality of local peaks that havebeen frequency-shifted down to frequencies with harmonics at theinfrared frequencies, and at least one of the local peaks are selectedas key frequencies of the resonant frequency pattern of the formulasample.

In certain embodiments, the therapy applied to the patient is anelectromagnetic therapy, which has a pulsed electromagnetic field devicethat delivers a pulsed electromagnetic field to the patient, and thepulsed electromagnetic field and the replicated key frequencies of theformula sample are simultaneously delivered to the patient. In furtherembodiments, the therapy applied to the patient is a non-electromagnetictherapy, which is one of a pharmaceutical compound, a physical andchiropractic therapy, a homeopathy therapy, an acupuncture therapy,psychological counseling, Qigong medicine, and Ayurvedic medicine. Insome embodiments, a plasma generator imprints the device with theplurality of key frequencies from the resonant frequency pattern of theformula sample, the plasma generator comprises a vessel that defines anenclosed volume, and the plasma generator strikes an inert gas in theenclosed volume into a plasma state, which imprints the device with theplurality of key frequencies.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplified schematic diagram of muscle circuit as mentionedabove.

FIG. 2 is a diagram of a plasma system for imprinting the device of thepresent invention.

FIG. 3 is a simplified flow diagram of a method of imprinting for thedevice of the present invention.

FIG. 4A shows two therapeutic resonant frequency pattern devices stackedon top of each other and placed directly on a patient.

FIG. 4B shows two therapeutic resonant frequency pattern devices and adelivery mechanism having a coil or two electrodes, wherein the twodevices and the coil or electrodes are placed in a housing, which isthen positioned on a patient.

FIG. 5A shows a therapeutic resonant frequency pattern device placedover a muscle or muscle group of a patient.

FIG. 5B shows a therapeutic resonant frequency pattern device and adelivery mechanism having a coil or two electrodes, wherein the deviceand the coil or electrodes are placed in a housing, which is thenpositioned over a muscle or muscle group of a patient.

FIG. 6 is a simplified flow diagram of the method of using or applyingthe device of the present invention.

FIGS. 7A-7C show additional embodiments of the invention that catalyze aresponse of a patient to a therapy.

FIG. 8 is a graphical representation of data obtained duringproof-of-concept testing showing improvements in muscle function.

FIG. 9 is another graphical representation of data obtained duringproof-of-concept testing showing improvements in muscle function.

FIG. 10 is another graphical representation of data obtained duringproof-of-concept testing showing improvements in pain and mobility afteran extended period of time.

FIG. 11 shows the percentage change in peak force observed between thetest conditions, results from the interim analysis of the Pilot Studydescribed in the Examples section of this disclosure. A significantdifference was observed in change in peak force between experimental andcontrol subjects, p<0.05. Additionally, the Threshold represents ameaningful change in force, based upon published literature.

FIG. 12 shows the mean EMG Root Mean Square for the three testconditions, results from the interim analysis of the Pilot Studydescribed in the Examples section of this disclosure. A significantdifference was observed between Chip Applied and Post “Treatment” forExperimental Subjects, p<0.05.

FIG. 13 shows the relationship between the peak force and the mean EMGRoot Mean Square for the three test conditions, results from the interimanalysis of the Pilot Study described in the Examples section of thisdisclosure. A reasonable linear relationship was observed for peak forceand mean EMG RMS.

FIG. 14 shows an example of an individual relationship between the peakforce and the mean EMG Root Mean Square for the three test conditions,experimental subject 10, anterior deltoid muscle, results from theinterim analysis of the Pilot Study described in the Examples section ofthis disclosure.

DETAILED DESCRIPTION

Referring to FIG. 2, a plasma generator system 10 is provided forimprinting doped glass or other material with the resonant frequencypattern (RFP) of a formula sample of a bioactive substance, apharmaceutical, or other compounds. A method for using the plasmagenerator system 10 to imprint doped glass or other material is providedin FIG. 3. The plasma generator system 10 comprises a vessel 12 in whichthe target doped glass are placed. The vessel 12 in this embodiment is ahollow cylindrical tube that defines an enclosed volume. Two glassslides 14 are placed in the vessel 12, and two doped glass pieces 16 areplaced on each slide. It will be appreciated that the doped glass 16 canbe placed directly in the vessel 12 in some embodiments, and while thedoped glass 16 may be 20 mm Swarovski glass crystals in variousembodiments, the target material may not be glass. The target materialmay be any material capable of receiving a RFP from a formula sample.

Next, another glass slide with a formula sample 18 is positionedupstream of the glass slides 14 with the doped glass 16. Upstream inFIG. 2 is a position that is left of the glass slides 14 and doped glass16 since an inert gas in a plasma state flows from left to right in thevessel. The formula sample 18 has a RFP, which as described herein, canbe determined by the nuclear magnetic resonance spectrum, the infraredvibrational spectrum, or other frequency-based characteristics of theformula sample.

An electromagnetic field generator strikes the argon gas into a plasmastate and comprises a function generator 10, an impedance matcher 22,and an amplifier 24. The function generator 10 can generate anelectronic signal with a frequency between 10,000 Hz and 1000 MHz with atypical operating range between 40 kHz to 40 MHz and specificfrequencies at 450 kHz, 2 MHz, 4 MHz, and 27.12 MHz. The functiongenerator 10 in this embodiment generates an electronic signal atapproximately 700 mV p-p with a frequency of approximately 13.56 MHz,which is a typical frequency for striking argon gas into a plasma state.

The impedance matcher 22 in FIG. 2 helps match the impedance between thefunction generator 20 and the amplifier 24 to improve the quality of thesignal sent from the function generator 20 to the amplifier 24 and tomaximize power transfer and/or minimize reflection between the functiongenerator 20 and the amplifier 24. The amplifier 24 receives theelectronic signal from the function generator 20 and increases themagnitude of the electric potential difference, or voltage. In thedepicted embodiment, the amplifier 24 increases the voltage of theelectronic signal to 80 V. The amplifier 24 outputs to a coil 26 that iswrapped around an exterior surface of the vessel 12. The coil 26 has atleast one turn, and as a consequence, the amplified electronic signalfrom the amplifier 24 and the coil 26 produces an electromagnetic field.The area of the vessel 12 that is surrounded by the coil 26 may bereferred to as a formula area, and the glass slide with the formulasample 18 may be at least partially disposed in the formula area.

Further components of the plasma generator system 10 are the pump 28 andargon tank 30. The pump 28 is used to remove the ambient air from theenclosed volume of the vessel 12, and the argon tank 30 backfills theresulting vacuum with argon gas. The electromagnetic field generatorstrikes the low pressure argon gas in the vessel 12 to create a plasmathat imprints a RFP from the formula sample 18 to the doped glass 16.Remote plasma is used in this embodiment, however, it will beappreciated that a standard plasma may also be used in embodiments ofthe present invention.

Referring to FIG. 3, a method 34 of imprinting doped glass using aplasma generator system is provided. The imprinting method 34 comprisesa series of exemplary steps that describe the use of an inert gas in aplasma state to imprint the RFP of a formula sample to doped glass,which can then be used to for the therapeutic benefit of a patient.

In the first step 36, doped glass is placed onto glass slides in avessel of the plasma generator system. The doped glass is at leastpartially positioned in a formula area of the enclosed volume defined bythe vessel so that the doped glass is subject to the electromagneticfield produced by the electromagnetic field generator.

The next step 38 is to distribute a formula sample having a RFP on theglass slide. In this embodiment, the formula sample is shaped on theglass slide so as to not impede the flow of argon gas over of theformula sample. However, it will be appreciated that in otherembodiments, the shape of the formula sample, or another component ofthe plasma generator system, may induce turbulent flow in the vessel toincrease the momentum transfer between the plasma and other components.

The vessel is sealed 40 at both ends to fully enclose the volume definedby the vessel. A pump at one end of the vessel is activated to draw theambient air out of the enclosed volume of the vessel and produce avacuum. The pump draws a 115 mTorr vacuum in the vessel.

Then, an argon tank at the opposite end of the vessel releases 42 theinert gas argon into the enclosed volume of the vessel, and the pressureof the vessel rises to 170 mTorr. The result is a vessel filled with lowpressure argon gas. The pump and the argon gas tank can be activatedduring one or more steps of the method 34 to maintain a low pressureargon gas flow over the formula sample and the doped glass. The lowpressure argon gas flows from the argon gas tank to the pump, and theformula sample in this embodiment is therefore upstream of the dopedglass.

The electromagnetic field generator, which comprises a functiongenerator, an impedance matcher, and an amplifier with coils around theformula area, produces 44 an electromagnetic field to strike the lowpressure argon gas into a plasma state. The gas is in a plasma state inthe vessel for approximately 15 minutes to imprint 46 the doped glasswith the RFP of the formula sample. Once 15 minutes has expired, thevarious components of the plasma generator system are powered down 48.The pressure in the vessel is allowed to rise back to ambient pressure,and the doped glass in the vessel are recovered and are now imprintedwith the RFP of the formula sample.

It will be appreciated that the method 34 described with respect to FIG.2 is exemplary in nature, and the particular components and valuesdescribed may vary. For example, in some embodiments, the pump may drawa vacuum down to 130 or 140 mTorr before argon is introduced to theenclosed volume to raise the pressure in the enclosed volume of thevessel to 170 or 220 mTorr. In an additional example, the amount of timethat the doped glass is subjected to the plasma can be greater than orless than 15 minutes. Additionally, inert gases besides argon, and othergases capable of striking into a plasma state such as oxygen, can beused in embodiments of the present invention.

Alternatively, there are other devises and methods for imprinting adevice with the RFP of a bioactive substance, a pharmaceutical, or othercompounds. A device such as doped glass may be imprinted with a RFPusing a pulsed electromagnetic frequency (PEMF) device. First, a formulais prepared, which may be a mixture of bioactive substances, anddifferent formulas may target different physiological systems andconditions of a patient's body. For example, formulas may target musclefunction (i.e., a muscle formula), tissue oxygenation (i.e., a hypoxicformula), etc. Other formulas may target neurological function, nervoussystem function, the digestion system, the immune system, organfunction, depression, inflammation, various disease states, and otherphysiological systems and conditions. Formulas in some embodiments maybe derived from oxygen alone or in combination with other compounds.Various bioactive substances that have a RFP may include biomolecules,cells, tissues, connective tissue, collagen (i.e. organs, bone marrow),plasma, hemoglobin, nucleic acids, DNA, RNA, enzymes, proteins, aminoacids, peptides, polypeptides, carbohydrates, saccharides, lipids,signaling molecules, neurotransmitters, hormones, pheromones,immunogenic system substances, pathogens (i.e. Polio virus, malaria),nutrients, pharmaceuticals, biologics, and other biogenic substances.

Next, the formula is added to a solution, which in some embodiments is awater/ethanol mixture. It will be appreciated that while the formula maybe added to a fluid, the formula may also be utilized as a solid such asa powder. In the next step, the solution is added to a chamber. In someembodiments, there is only a single chamber. However, in otherembodiments, there are additional chambers, for example, two chambers,three chambers, etc. In a two chamber configuration, a second chambermay be at least partially disposed in the first chamber. The solution islocated between the two chambers, and the second chamber creates avolume that is surrounded by the solution. A device or other target thatis to be exposed to a wave may be placed in the second chamber.

The chamber, or chambers, may have a variety of characteristics toaccommodate the process. The shape of the chamber may be any shape thatdefines a partially enclosed volume. For example, the chamber may have acircular cross section with an aperture at one end of the chamberconfigured to receive the formula. The chamber may also optionallycomprise a lid to cover the aperture and fully enclose the volume. Thematerial of the chamber may be electromagnetically transparent to allowelectromagnetic waves to pass through the chamber and interact with theformula and the device. Examples of chamber materials include quartz,borosilicate glass, and inert plastics.

Next, a PEMF device is placed proximate to the chamber. The PEMF devicegenerates an electromagnetic wave with a pulse frequency or frequenciesbetween approximately 0.5 and 50 Hz. The peak amplitude of the magneticfield generated by the PEMF device may be less than 10000 gauss, and insome embodiments, the PEMF device may not generate power above afrequency of 100 kHz. A device is positioned at least partially withinthe chamber, and the device is positioned such that it is opposite thePEMF device. In other words, the formula is positioned between thedevice and the PEMF device. The solution of formula may be characterizedby optical depth, which is a dimensionless parameter that is the naturallogarithm of the ratio of incident to transmitted radiant power througha material. In various embodiments, the solution through which the wavepasses through has an optical depth of between approximately 0.01 and 4.

In subsequent steps, the PEMF device is activated, and the formula andthe device are exposed to the PEMF's electromagnetic wave. The period ofthe pulse may last between approximately 2 to 600 seconds to transferthe therapeutic RFPs of the formula to the device. The resultingimprinted device may comprise only the device itself. However, it willbe appreciated that in other embodiments, the device may be optionallycombined with other components such as a mineral matrix layer or aprotective layer, to create an imprinted device.

While a PEMF device is used, other wave sources may be used to generatewaves that pass through the chamber, the formula, and into the device.In one exemplary method, a sample of the aqueous alcohol/solution isplaced into a Pyrex or quartz chamber. The sample might contain 5-1000ml of the solution. One or more devices are placed within a second Pyrexor quartz container, which is placed within the first chamber so thatthe solution surrounds the targets. Both chambers are placed within anapparatus capable of generating oscillating electromagnetic fields. Thefield generator is activated, and the targets are exposed for a periodof time; the oscillating electromagnetic field serves as a carrier waveto transfer the RFPs of the formula to the device. The frequency orfrequencies of the electromagnetic field can vary from low through radioand microwave frequencies and combinations thereof. The RFPs have beenshown to be retained or imprinted on the device.

In some embodiments, the wave source generates an electromagnetic wavehaving a frequency or frequencies in the range of infrared light (300GHz-400 THz), visible light (400 THz-770 THz), and/or ultraviolet light(770 THz-30 PHz). The chamber or chambers used in these embodiments mayhave configurations and dimensions as discussed elsewhere herein, forexample, the chamber has a portion that is optically transparent. Thepower of the wave source may be less than 100 W, and the period of timethat the device is exposed to the wave may be between approximately 2and 600 seconds. Other components may be utilized along the transmissionpath between the wave source and the chamber or chambers, includingcollimating lens for narrowing the wave and diverging lenses forexpanding the wave.

In yet another exemplary method, a sample of the aqueousalcohol/solution is placed into a quartz chamber. The sample mightcontain 5-1000 ml of the solution. The quartz chamber containing thesolution is placed into an apparatus in which a continuous-wave orpulsed laser passes through a beam-expanding lens and the quartzchamber, to fully illuminate a target device. The laser is activated,and the target exposed for a period of time; the laser beam serves as acarrier wave to transfer the RFPs of the formula to the device. The RFPshave been shown to be retained or imprinted on the device.

In further embodiments, the wave source generates an electromagneticwave having a frequency or frequencies in the range of radio waves (3Hz-300 MHz) and/or microwaves (300 MHz-300 GHz). A Gunn diode or anamplified signal generator may serve as the wave source. The peak powerof the emitted waves may be less than 100 W, and the length, width, andheight of the chamber may each vary between approximately 2-50 cm. Theperiod of time that the device is exposed to the wave may be betweenapproximately 2 and 600 seconds.

In yet further embodiments, the wave source generates an electromagneticwave having a frequency or frequencies in the range of low-frequencywaves (below 3 kHz). A signal generator with an optional amplifier mayserve as the wave source. The peak power of the emitted waves may beless than 100 W, and the length, width, and height of the chamber mayeach vary between approximately 2-50 cm. The period of time that thedevice is exposed to the wave may be between approximately 2 and 600seconds.

In other embodiments, a magnetic source generates a magnetic field(i.e., wave) that passes through the chamber through the formula, andinto the device. A first coil may be positioned at a first end of thechamber. A signal generator may supply power of less than 10 W into thefirst coil to directly expose the formula and the device to a magneticfield. The first coil may have a resistance of 50 ohms. In furtherembodiments, a second coil is positioned at a second end of the chamber,and the first and second ends may be arranged opposite each other. Athird coil is positioned at a base of a second chamber, and connectedvia an appropriate resistance to form an electrical circuit with thesecond coil, and the formula is placed in the first chamber. Supplying asignal and power to the first coil induces a response in the third coilthat generates a magnetic field. The length, width, and height of thechamber may each vary between approximately 2-50 cm, and the period oftime that the device is exposed to the magnetic field may be betweenapproximately 30 and 600 seconds.

In various embodiments, the wave source generates a mechanical wave suchas an acoustic wave. An exemplary wave source may be a speaker with astrong frequency response below 200 Hz, and the chamber may be made froman acoustically-transparent material or have an acoustically-transparentsection oriented toward the transmission path of the acoustic wave. Theenergy supplied to the speaker may be less than 100 W. The length,width, and height of the chamber may each vary between approximately2-50 cm, and the period of time that the device is exposed to themagnetic field may be between approximately 2 and 600 seconds. Variouswaveforms may be used in conjunction with the embodiment described withrespect to FIG. 2. These waveforms include those described elsewhereherein. Various embodiments may further comprise a protective cover thatcontains the waves transmitted through a formula and into a device. Theprotective covers can be made from shapes and materials that allow theprotective cover to function as a Faraday cage.

A single device may be imprinted with one or more therapeutic RFPs, andthere are several systems and processes to imprint a device with thetherapeutic RFPs of multiple formulas. First, a device may be imprintedwith therapeutic RFPs serially. In one example, the device is subjectedto a wave passing through a formula, and the device is imprinted withthe therapeutic RFPs associated with the formula. Then, the device issubjected to a wave passing through a hypoxic formula, and the device isimprinted with the therapeutic RFPs associated with the hypoxic formula.Thus, the resulting device is imprinted with therapeutic RFPs associatedwith both the formula and the hypoxic formula.

Second, the device may be imprinted with therapeutic RFPssimultaneously. This means that a composite formula may be formed fromone or more constituent formulas. For example, a formula and a hypoxicformula may be combined to form a composite formula. Then, a wavepassing through the composite formula imprints therapeutic RFPs on thedevice where the therapeutic RFPs as associated with both the formulaand the hypoxic formula. The imprinting process in various embodimentsmay employ any wave generation processes discussed herein, includingthose associated with the subsequent excitation of the RFPs from theimprinted device. In addition, the imprinting methods described withrespect to FIG. 2 create a first generation device. A first generationdevice may be excited to imprint RFPs onto another device. This secondimprinted device is a second generation device. The process may becontinued to create any number of generation devices.

Referring to FIG. 4A, a first device 32 a and a second device 32 b areprovided without a delivery mechanism. In some embodiments, a deliverymechanism may be optionally included depending on a number of factors,including the patient's ailment. The delivery mechanism may activate,modulate, or amplify RFPs among other actions. As described above, thecontraction of the muscle alone may provide the excitement necessary togenerate frequency responses from the device 32 a or carrier layer. Thecontraction of a muscle may be sufficient when the patient's ailment isa simple muscle strain or other imbalance. However, some patient'sailments prevent the contraction of a muscle or other bodily movementthat excites the RFPs imprinted in the device 32 a or carrier layer. Forexample, muscular dystrophy or multiple sclerosis patients may not havea complete range of motion or muscle response to sufficiently excite thedevice 32 a. Therefore, the delivery mechanism provides excitation tothe device 32 a when there is no other excitation. It will beappreciated that a delivery mechanism may also be used on any patient toenhance or supplemental existing excitation.

The device's 32 a, 32 b in FIG. 4A are stacked on top of each other andmay comprise different materials. The first device 32 a may comprise afirst composition, and a second device 32 b may comprise a secondcomposition. For example, the first device may be imprinted with theRFPs of a muscle formula as discussed elsewhere herein, and the seconddevice may be imprinted with the RFPs of a hypoxic formula. In furtherembodiments, multiple compositions, devices, carrier layers, orsubstrates may be combined into a single device 32 a.

Mechanical waves include acoustic waves generated by devices such as apiezoelectric transducer and other similar devices. In some embodiments,an acoustic resonator such as a tuning fork may have a frequency rangebetween approximately 62 Hz and 4111 Hz, wherein the tuning fork mayexcite a resonance frequency in a layer. Other delivery mechanisms mayproduce ultrasonic waves, which are acoustic waves above the range ofnormal human hearing. Delivery mechanisms 50 that generate mechanicalwaves may comprise a frequency generator to control the wave frequencyor frequencies, wave form, and wave amplitude among other attributes ofthe mechanical wave. In a specific example, a FG085 MiniDDS FunctionGenerator is connected to a sheet or membrane with alligator clips orother means of operative connection. The membrane in this embodiment haspiezoelectric properties, meaning electric charge accumulates inresponse to mechanical stress, or vice versa. A particular frequency orfrequencies, wave form, and amplitude may be applied to the membrane toalter the properties of the membrane, for example, to match the signalof compounds or bodily components. After an embedding step, the membranemay be used as a substrate or carrier layer or may be added incombination with any layer of the device 32 a.

Referring to FIG. 4B, a first device 32 a and a second device 32 b areprovided with a delivery mechanism 50. In the realm of electromagnetism,the source of an electromagnetic wave may come from a variety ofelectromagnetic delivery mechanisms 60. For example, frequencygenerators, Pulsed Electromagnetic Fields (“PEMF”), TranscutaneousElectrical Nerve Stimulation (“TENS”), LASERs, and other similar devicescan be used as a delivery mechanism 50 to excite a frequency response inthe device 32 a. As shown in FIG. 4B, a delivery mechanism 50 maycomprise a cable 52 that extends from a main body or housing of thedelivery mechanism 50. The cable 52 transmits an electromagnetic wave tothe devices 32 a, 32 b and/or the patient. It will be appreciated that aplurality of cables 52 may be employed, including cables 52 that connectto the delivery mechanism 50 at a single location, not two locations asshown in FIG. 4B. Similarly, a plurality of delivery mechanisms 50 maybe employed.

The cable 52 may be positioned in a particular arrangement relative tothe devices 32 a, 32 b. For example, the cable 52 may be arranged in acoil shape around the devices 32 a, 32 b when the devices 32 a, 32 b areplaced over or in proximity to the tissue to be treated. To preservethis arrangement, the cable 52 and the devices 32 a, 32 b may be placedinto a housing 54 defining a partially enclosed volume such as a pocket.Then the housing 54 is placed over or proximate to a patient's tissue ormuscle for therapeutic treatment.

In some embodiments, the delivery mechanism's 50 cable 52 is arrangedaround the outer perimeter of the one or more devices 32 a, 32 b tomaximize the contact area between the cable 52 and the devices 32 a, 32b. In various embodiments, the cable 52 is arranged in a coil having adiameter between approximately ½″ and 10″. In some embodiments, thecable 52 is arranged in a coil having a diameter between approximately4″ and 7″. In one embodiment, the cable 52 is arranged in a coil havinga diameter of approximately 5.5″. The number of turns the cable 52 makesupon itself may be any number of turns, including one, two, three, four,five, etc. The thickness of the cable 52 in some embodiments may bebetween approximately 0.5″ to 2″ thick.

In other embodiments, the cable 52 may be arranged in a coil have adiameter that is less than one or more devices 32 a, 32 b. In theseembodiments, the cable 52 may rest on top of the electrodes, or thecable 52 may be positioned between devices 32 a, 32 b. In yet otherembodiments, the cable 52 is arranged in a coil have a diameter that isgreater than the one or more devices 32 a, 32 b, which creates a space.In some embodiments, this space may be between approximately 0.1″ and2″. In various embodiments, this space may be between approximately0.25″ and 1″.

Referring to FIGS. 5A and 5B, a single device 32 may be utilized with orwithout a delivery mechanism 50 as described in FIGS. 4A and 4B,respectively. As described elsewhere herein, a single device 32 may beimprinted with therapeutic RFPs associated with a single formula such asa hypoxic formula. In other embodiments, the device 32 may be imprintedwith more than one therapeutic RFPs associated with more than oneformula. In some embodiments, the device 32 is imprinted withtherapeutic RFPs associated with both a hypoxic formula and anotherformula. These multiple therapeutic RFPs may be imprinted serially orsimultaneously. PEMF devices emit pulsations of electromagneticradiation. The pulse wave or rectangular wave form is the preferred waveform associated with PEMF delivery mechanisms. However, PEMF deliverymechanisms may also utilize sine waves, square waves, triangle waves,saw-tooth waves, and any other waveform commonly known in the art, orwaveforms of arbitrary shape constructed to efficiently conveytherapeutic RFPs to affected tissue. Other important parametersassociated with the PEMF delivery mechanism include the frequency orfrequencies of the electromagnetic radiation and the amplitude of theelectromagnetic radiation, wherein the parameters are independentlyadjustable. PEMF delivery mechanisms used in combination with devices 32described elsewhere herein can be used to treat pain, including chronicpain. Further literature regarding the benefits of PEMF treatment may befound in Rheumatol Int (2010) 30:571-586; Alternative Therapies,July/August (2003), Vol. 9 No. 4, 38-48; and Cell Biochem Biophys (2013)67:1229-1237, which are incorporated herein in their entirety byreference.

For the PEMF delivery mechanism and other delivery mechanisms thatutilize electromagnetic radiation, a variety of frequencies may beutilized. For example, radio waves (3 Hz-300 MHz), microwaves (300MHz-300 GHz), infrared light or waves (300 GHz-400 THz), visible light(400 THz-770 THz), ultraviolet light (770 THz-30 PHz), X-rays (30 PHz-30EHz), gamma rays (more than 30 EHz), and low-frequency waves (below 3kHz) are all frequencies that the electromagnetic delivery mechanismsmay utilize. Typically, lower frequencies are preferred in theutilization of PEMF devices as a delivery mechanism. In someembodiments, the PEMF delivery mechanism produces a frequency orfrequencies less than approximately 3,000 Hz. In further embodiments,the PEMF delivery mechanism produces a frequency or frequencies lessthan approximately 100 Hz. In yet further embodiments, the PEMF deliverymechanism produces a frequency or frequencies less than approximately 24Hz.

In one embodiment, a device may be imprinted with frequencies thatcorrespond with the natural resonance of oxygen molecules or otheroxygen substances, which typically ranges between 57 and 64 GHz.Further, the device may be excited with these frequencies. Anoxygen-specific device may be used alone or in combination with otherdevices described elsewhere herein.

Further, a frequency sweeping option may be utilized withelectromagnetic delivery mechanisms. In one embodiment, the frequencysweep occurs between a first and a second reference frequency over aperiod of time. In some embodiments, the reference frequencies areapproximately 0.5 Hz and 32 kHz. Reference frequencies may also includeSchumann resonances (7.83 Hz and harmonics thereof, including 14.3,20.8, 27.3, and 33.8 Hz). Further, reference frequencies can include anyfrequency of the electromagnetic spectrum. The frequency sweep occursover time, but the sweep is not necessarily a continuous sweep betweentwo reference frequencies. For example, a delivery mechanism may emit afirst reference frequency for a first time period, and second referencefrequency for a second time period, a third reference frequency for athird time period, and so on. One skilled in the art will appreciatevarious combinations of references frequencies and time periods toimplement a frequency sweep option for a delivery mechanism.

One particular example of a PEMF is a device which pulses current toproduce a pulsed electric field. This is significant because the coilapplicator can be turned to provide predominately positive orpredominately negative fields to the body. Using approximately 160volts, it is possible to pulse electromagnetic waves with a frequency orfrequencies less than 20 kHz and a lower magnetic strength limit of10,000 gauss. In some embodiments, the voltages for the PEMF device mayrange between approximately 120 to 240 Volts. In various embodiments,the electromagnetic waves may be as low as 100 MHz. Further, in certainembodiments, the magnetic strength of the PEMF device may be betweenapproximately 1 to 30,000 gauss. Further yet, in some embodiments, themagnetic strength of the PEMF devices may be between approximately 2,400to 21,000 gauss.

PEMF delivery mechanisms and other delivery mechanisms may be used withone or more devices according to treatment protocols discussed elsewhereherein. For example, referring to the protocol discussed in FIG. 6, ifthere is an observed, isometric contracting or “unlocking”, then atblock 64, the device is placed on the muscle or group of muscles, or inother embodiments, the device is placed over or in proximity to theparticular tissue or muscle along with a delivery mechanism. The variousparameters of the PEMF delivery mechanism may be adjusted for aparticular patient and/or a particular ailment. For example, autoimmuneissues may require lower amplitude and higher frequency electromagneticwaves while neurological issues may require higher amplitude and lowerfrequency electromagnetic waves. Then, the protocol proceeds like theprotocol in FIG. 6 and then at step 72 the device and delivery mechanismare removed from the patient.

Next, TENS delivery mechanisms utilize an electric current for nervestimulation. TENS devices may modulate the pulse width, frequencies,amplitude, wave form, etc. of electromagnetic waves. Generally, TENS isapplied at high frequency (>50 Hz) with an intensity below motorcontraction (sensory intensity) or low frequency (<10 Hz) with anintensity that produces motor contraction. Typically, the TENS devicesincludes one or more electrodes to deliver the electromagnetic wave.Dermal patches may be incorporated to adhere the electrode to a portionof a user's skin such that electrode is fixed relative to a muscle ormuscle group. One skilled in the art will appreciate that a patch orother similar device may be used with other delivery mechanisms such asthe PEMF device to secure the delivery mechanism relative to the muscleor muscle group.

In one particular example of the present invention, the carrier layer isa quartz crystal with a particular size and cut. A quartz crystal haspiezoelectric properties wherein an electric field distorts the physicalshape of the quartz crystal. When the electric field is altered thequartz crystal changes shape and generates an electric field of its own.The rate of expansion and contraction of the quartz crystal can be theresonance frequency or resonance frequencies of the carrier layer. Inother embodiments, fused silica, which is a non-crystalline form ofsilicon dioxide, may be used in combination with quartz or substitutedin place of quartz.

In some embodiments of the present invention, the portion of the device32 that comprises a resonance frequency may be heated or cooled toaffect the performance of the layer. In one embodiment, the carrierlayer comprises a resonance frequency. The carrier layer may be heatedor cooled when the carrier is placed in proximity to the muscle ormuscle group, and the delivery mechanism is placed in proximity to thecarrier layer. Depending on attributes of the carrier layer such as thecut, the change in temperature can affect the frequencies generated bythe excitation of the carrier layer, and the change in temperature candirectly enhance the therapeutic on the user.

Referring to FIG. 6, a simplified flow diagram is provided forexplanation of one preferred embodiment of the method of the invention.At block 56, as a first step, a caregiver locates a muscle imbalance. Atblock 58, the affected body part is positioned so that the targetedmuscle is in the furthest state of contraction. This contracted positionis held for approximately 5 seconds. At block 60, the muscle is testedfor an indicator change by applying a steady, consistent pressure. Ifthere is no indicator change, that is, if there is no observed,eccentric contraction, “unlocking”, or failure of the muscle, then atblock 62, the patient continues to be checked/evaluated for other muscleimbalances. If there is an observed, eccentric contraction or“unlocking”, then at block 64, the device 32 is placed on the muscle orgroup of muscles, or in other embodiments, the device 32 is placed overor in proximity to the particular tissue, muscle, or muscle group. Atblock 66, the targeted/imbalanced muscle is again placed in its furtheststate of contraction. At step 68, increasing pressure is applied forapproximately 5 seconds to activate the muscle fibers, and theassociated spindle cells, golgi tendon organs and golgi ligament organs.This activity of block 68 is repeated a number of times, shown at block70. During this repeated application of pressure over 5 second timeperiods, the caregiver should observe improved muscle function. Inclinical trials, it has been shown that repeating this activity three orfour times has been adequate to resolve many muscle imbalance problems.At step 72, the device 32 is removed from the patient, and the muscle isallowed to rest for a period of time, preferably for about 2 minutes. Atstep 74, the muscle is retested by placing the muscle back to itsfurthest state of contraction. If the procedure has been successful, thetargeted muscle(s) should now isometrically contract lock stronglyagainst monitoring pressure.

The method described in reference to FIG. 6 prescribes placement of thedevice 32 on the muscle or group of muscles; however, it should beunderstood that the device 32 can be placed upon other body parts, tospecifically include those muscles and muscle groups that have beenfound to have an imbalance. Additionally, although the method describedprescribes application of repeated and progressively increasing pressureover 5 second time periods, other methods of the present invention mayinclude other protocols for application of pressure over other timeperiods, as well as the number of cycles in which pressure is applied.For example, for some muscle groups, it may be found that applyingpressure over lesser or greater time periods may be preferred. As bestunderstood, the resonance frequencies are transmitted to the patientpassively. For instance, the movement of the individual muscle or musclegroup excites a frequency response from the device 32. In otherembodiments, a delivery mechanism may be used to actively excite afrequency response from the device 32.

In an alternative embodiment, the patient has a more active role in thesteps at blocks 56, 58, 60 wherein the user performs a predeterminedmotion. Then, depending on the effort required to perform thepredetermined motion, a muscle or tissue imbalance may be located. Thedevice and other components described herein may be placed over theparticular muscle or tissue imbalance for a predetermined time. In someembodiments, the predetermined time is between approximately 2 to 10minutes. Next, the patient may re-perform the predetermined motion forthe steps at blocks 66, 68, 70 to observe if more treatment is required.In various embodiments, multiple devices and associated components maybe deployed on a patient to achieve the desired effect.

Data has been collected in a proof-of-concept study and an IRB-approveduniversity trial assessing muscle function using the device and methodof the invention. In initial clinical studies the invention has beenshown to reliably produce consistent improvements in muscle function.One common measure of muscle function is termed Electromyography or EMGthat measures the electrical activity of the individual motor units asthey shorten during contraction. In EMG, the Electromyograph is attachedto a recording electrode which is either a needle inserted into themuscle to record muscle activity, or to a transcutaneous electrode thatrecords electrical activity of the muscle from the surface of the skin.In the university study, transcutaneous electrodes were used. When themuscle is attached to either needle or transcutaneous electrodes, muscleactivity is measured by electrical frequencies sent to theElectromyograph, which can then convert these raw frequencies intoseveral types of electromyograms (EMGs). One common type ofelectromyogram is called an Integrated Power Spectrum. This graphicallypresents the number of motor units actively contracting in the muscleover time and is measured in millivolts. The greater the number of motorunits contracting at any one time indicates a stronger musclecontraction.

Additional embodiments of the invention are provided in FIGS. 7A-7C thatcatalyze a response of a patient to a therapy. Referring to FIG. 7A, adevice 76 may be imprinted with key frequencies of the resonantfrequency pattern of the formula sample, and the device 76 may beimprinted with the key frequencies using, as described herein, a plasmagenerator system, a PEMF device, etc. During operation, the imprinteddevice 76 is placed proximate to or on a patient 80. Then, a therapy 78is applied to the patient, and the therapy 78 may be an electromagnetictherapy or a non-electromagnetic therapy. One example of anelectromagnetic therapy is a PEMF device delivering a pulsedelectromagnetic frequency to the patient. The imprinted device and thekey frequencies imprinted in the device catalyze the response of thepatient to the electromagnetic therapy. Examples of non-electromagnetictherapies include, but are not limited to, a pharmaceutical compound, aphysical and chiropractic therapy, a homeopathy therapy, an acupuncturetherapy, psychological counseling, Qigong medicine, and Ayurvedicmedicine. Again, the imprinted device and the key frequencies imprintedin the device catalyze the response of the patient to thenon-electromagnetic therapy.

FIG. 7B shows another embodiment of the invention that combines or mixesfrequencies from multiple sources. Key frequencies 82 of a resonantfrequency pattern of a formula sample are generated by an arbitrarywaveform generator, and a PEMF device produces pulsed electromagneticfrequencies 84. A nonlinear element 86 such as a diode combines theseelectronic signals 82, 84 into a mixed electronic signal. Specifically,nonlinear element 86 can combine the key frequencies 82 and the sum anddifference frequencies of the key frequencies 82 with the pulsedelectromagnetic field frequency 84. An amplifier may increase theamplitude of the mixed electronic signal before the mixed electronicsignal is sent to a transmitter 88 such as a coil or an antenna. Themixed electronic signal is transmitted to the patient 80, and theadditional of the key frequencies 82 to the pulsed frequency 84catalyzes a response of the patient to the pulsed frequency 84.

FIG. 7C illustrates an embodiment of the invention where key frequencies82 are replicated by an arbitrary waveform generator then delivered by atransmitter 88 to a patient 80 to catalyze a response of the patient 80to a therapy 78. Like the embodiment described with respect to FIG. 7A,the therapy 78 may be an electromagnetic therapy or anon-electromagnetic therapy. One example of an electromagnetic therapyis a PEMF device delivering a pulsed electromagnetic frequency to thepatient. The key frequencies 82 catalyze the response of the patient tothe electromagnetic therapy. Examples of non-electromagnetic therapiesinclude, but are not limited to, a pharmaceutical compound, a physicaland chiropractic therapy, a homeopathy therapy, an acupuncture therapy,psychological counseling, Qigong medicine, and Ayurvedic medicine.Again, the key frequencies 82 catalyze the response of the patient tothe non-electromagnetic therapy.

FIGS. 8 and 9 are graphical examples of muscle testing for two differentmuscles conducted in preliminary human pilot studies. In these examples,the subject's muscles became eccentrically contracted or “unlocked” whenmanually tested, and the muscles could only facilitate a small number ofmotor units when tested; accordingly, the muscles failed under onlymoderate pressure applied to the corresponding limbs of the muscles. Inboth examples the muscles were under-facilitated because not enoughmotor units could fire to fully facilitate the muscle and isometricallycontract or “lock”. As shown, the muscles tested were a middle deltoidmuscle (FIG. 8) and a pectoralis major clavicular muscle (FIG. 9). ThePreTest data (the PreTest referenced in the legends of the graphs ofFIGS. 8 and 9) reflects the states of the muscles when initiallyevaluated.

In one test, the device 32 is applied to a muscle or group of muscles,and the arm moved into the test position, where its fibers were alignedand shortened to provide maximal mechanical advantage during the test.With both muscles there was a dramatic increase in the number of motorunits recruited (activated) by the pressure applied to the arm toisometrically contract or “lock” the muscle and hold it in placethroughout the 5 to 6-second duration of the muscle test while thedevice 32 was applied to the muscle or group of muscles. As shown in thetest data, there was a rapid increase in the EMG power spectrum of bothmuscles as pressure was applied, then sustained full 5 to 6 secondspressure was applied, and then the rapid return to baseline once thepressure had ceased.

The device 32 was removed from the muscle or group of muscles, and aftera 3 to 5 minute rest period, the muscle was tested once again, (thislater test referenced as the Posttest in the legends of the graphs). Asshown, both muscles recruited even a larger number of motor units thanwhen the device 32 was being applied to muscle or group of muscles. ThePosttest data indicates that the muscles developed a full isometriccontraction or “lock” signifying a “reset” of the proprioceptors thathad been inhibiting these muscles before the treatment.

Referring to FIG. 10, this figure indicates that the effects fromapplication of the device 32 in a treatment appear to be long-lasting.In this Figure, the y-axis represents a range of mobility and a painscale in which 0 represents a state in which there is no mobility or nopain, and 10 represents a state in which there is full mobility ormaximum pain. This figure reflects data obtained in a proof of conceptstudy of a group of thirteen individuals with chronic shoulder pain andmuscle dysfunction who were treated only one time, yet this study groupshowed a greater than 77% increase in limb mobility (measured as afunction of a mobility scale from 1-10). The study group also showed anearly 62% reduction in pain ten weeks after treatment (measured as afunction of a pain scale from 1-10). As indicated in the graph of FIG.10, dark bars (left) represent patients that showed improvement for painand mobility, while the lighter bars (right) represent those patientsthat did not show measurable or appreciable improvement. The graph ofFIG. 10 clearly shows that patients did show improvement, particularlyin mobility.

In summary, the device and method of the present invention are capableof producing rapid improvement in muscle dysfunction. The therapeuticbenefits can be realized by evaluating a starting point in which amuscle is in a state of overt imbalance, and is transferred to a newstate of homeostasis in less than five minutes. Many of these rapidcorrections were evaluated as long-lasting.

The invention now being generally described will be more readilyunderstood by reference to the following example, which is includedmerely for the purposes of illustration of certain aspects of theembodiments of the present invention. The example is not intended tolimit the invention, as one of skill in the art would recognize from theabove teachings and the following examples that other techniques andmethods can satisfy the claims and can be employed without departingfrom the scope of the claimed invention.

Examples

This example provides an IRB-approved university study demonstrating theeffect of a muscle optimization (MO) device of the present invention onthe ability of the muscle to produce force and surface muscle energyactivity. The muscle optimization device is postulated to improve musclefunction by resetting muscle proprioception and improving musclestrength. Preliminary pilot studies using surface electromyography(EMG), described above, provided sufficient positive results to warranta full-protocol study with human subjects using both EMG and a forcegauge meter to test consistency and correlation.

The study is a Test-Retest design wherein the initial state of muscleimbalance was assessed with quantitative surface EMG. The muscleoptimization device was applied over light clothing on the muscle orgroup of muscles. The muscle with identified weakness was thenactivated, and force applied during testing the muscle was determined bya multi-directional force transducer, and the muscle response quantifiedusing surface EMG. The results were analyzed for correlation between theobjective force applied and the number of motor units recruited duringeach test. The major outcome measures are peak force generated andsurface EMG curve produced during isometric or eccentric musclecontractions.

Study subjects were selected from healthy, active athletes participatingin a variety of sports such as volleyball, tennis, racquetball,basketball, soccer, ice hockey, rock climbing, boxing, football,lacrosse or Nordic skiing. Participants were selected based onself-reports as being physically healthy, but who experienced muscleweakness in certain muscles/muscle groups, such as muscle imbalances ofthe shoulder joint: supraspinatus; middle deltoid; anterior deltoid;pectoralis major; clavicular division or latissimus dorsi. Studysubjects were between the ages of 18 to 35, reportedly in good health,with no acute shoulder injury, inflammation or pain. Those subjects whoreported a degenerative muscle condition or neurologic disease, such asmultiple sclerosis, or asthma, were excluded from the study.

Inclusion Criteria for the test subjects: To address the inherentvariability of muscle function, the study was limited to volunteersubjects who have an imbalance or weakness in one or more of thefollowing, easily isolatable muscles of the shoulder joint.

1. supraspinatus

2. middle deltoid

3. anterior deltoid

4. pectoralis major, clavicular division

5. latissimus dorsi

These muscles have been selected upon the basis of being accessible toattach the surface EMG electrodes, and agonists that can be isolatedwith respect to muscle fiber alignment and have limited synergistactivity until relatively higher force has been applied. These are alsoall muscles for which multiple-examiner reliability is high. Age:between the ages of 18 to 35

Sex: male or female Health Status: self-reported in good health, Sport:subjects will be active in a sport or training that may lead to over useor misuse of shoulder muscles, specifically: volleyball, tennis,racquetball, basketball, soccer, ice hockey, rock climbing, Nordicskiing, martial arts, crew.

Exclusion Criteria for the test subjects: Chronic illness or injury:Self-reported chronic shoulder problems; A degenerative muscle orneurologic disease such as Multiple Sclerosis or asthma: Previousinjuries, including acute shoulder injury, including inflammation orpain: Neck, whiplash, or spinal column injury(s); Past Surgeries: Asubject having undergone any past surgeries on arm, shoulder or neck.

Subjects participating in the study underwent muscle testing to identifyinhibited/weak selected upper body muscles. Identification of muscleinhibition or weakness was assessed by placing the subject's arm in thetest position and then asking the subject to “hold” against a pressureapplied by the experimenter via the held-hand force transducer. Theoutcome of the test was scored on a qualitative +3 Scale and assigned ascore of 1, 2 or 3. The direction of the pressure applied by theexperimenter (e.g. “hold” your arm up with the thumb turned downward, or“hold” your arm into your side, etc., will varied depending upon whichmuscle was being tested. Those subjects scoring a “3” on the muscle testwere assigned to the control group, subjects scoring a “1” or a “2” wereassigned to the experimental group. Surface EMG electrodes were placedon the surface of the skin over the inhibited/weak muscle (for theexperimental group subject), and over a standard muscle for the controlgroup, using standard electrode placement procedures. Replicate testswere carried out on each muscle selected for assessment in the followingsequence:

-   -   1) Control Test: Assessment of the initial muscle imbalance for        6 seconds (3 trials);    -   2) MO Device Test: Assessment of the muscle response with the MO        Device placed on    -   clothing above the muscle or group of muscles and the muscle        activated for 6 seconds (3 trials);    -   3) The Post-MO Device Test: Assessment of the muscle response        following MO Chip therapy with no Chip on the body for 6 seconds        (3 trials).        The amount of pressure was recorded using a hand-held force        transducer applied by the experimenter and the EMG signal was        recorded from the surface electrodes. Testing time for each        subject is estimated to be no longer then one hour.

Testing Protocol and preparation of selected muscles for SurfaceElectromyography (EMG): Muscles that have met the inclusion criteria(either a weak muscle or a control muscle) were prepared for surface EMGrecording and attached to the EMG to insure a good signal to noiseratio. The BioNomadix™ wireless EMG system (BioPac Inc.) is used tocollect the muscle activity data. First, the skin is cleaned using analcohol pad and the electrodes (EL500, BioPac Inc) are affixed to thesurface of the skin above the belly of the muscle of interest. Theground electrode is affixed to an area without muscle activity.

The force transducer (microFET2) is turned on using the on/off switch,and sensitivity setting set too high. The data recording software,ErgoPak, is launched on the PC, and the meter linked via the blue toothdongle with the software.

Muscle Test Position: The muscle(s) selected for monitoring are placedin their prescribed muscle testing position to reduce synergist(s)recruitment and to isolate the chosen muscle as much as possible as thePrime Mover or PM for that specific action. The arm is placed into thespecific test position in maximal concentric contraction to align themuscle fibers of the Prime Mover, and reduce recruitment of itssynergist(s). The subject is asked to “hold” their arm in this positionand informed by the monitor exactly how and in which direction pressurewill be applied. The subject is then asked to “hold” as the monitorbegins to slowly apply increasing pressure in the test direction overapproximately 2 seconds, and if the muscle isometrically contracts or“locks” to maintain that pressure for 2 seconds, then slowly release thepressure applied over approximately 2 seconds. The pressure applied isan appropriate force for the muscle tested. With this appropriate force,a clear isometric contraction or “Lock”, or eccentric contraction or“Unlock” is observed, and the results recorded. The test is repeatedthree times to obtain mean values for each muscle tested.

Muscle Optimization Device (MO) Procedure: Muscles that eccentricallycontract or “unlocked” in the screening testing, and the control musclewere re-tested after a Muscle Optimization Chip was placed on top ofclothing above subject's muscle or group of muscles, and the triplicatetesting repeated, as described above. Force-time record, surface EMGtime record and peak force were recorded. Rating of muscle function (1,2 or 3) by tester was recorded.

Muscle Optimization Device (MO) Re-Test Procedure: The MO was taken offand the muscle was re-tested in the triplicate testing proceduredescribed above. Three to five minutes were given between the initialtesting and the subsequent MO trials. Electrodes only remained affixedto the surface of a subject's skin for less than or equal to one hour intime.

A within-subject ANOVA was used to determine significant differencesbetween conditions in terms of the maximum pressure exerted, thetrial-to-trial variation in the pressure exerted, the mean peak EMGsignal, and the root mean square of the EMG signal. The surface EMGresults were presented graphically for each test condition, without theMO Device and with the MO Device on the muscle or group of muscles.

Results: As shown in FIG. 11, with results from n=14 subjects tested inthis Pilot Study, a significant difference has been observed in changein peak force between experimental and control subjects (p<0.05). The“Chip Applied” data refers to a peak force when a therapeutic device isbeing applied to a patient, which is contrasted with a pre-treatmentpeak forces. The “Post ‘Treatment’” data refers to a peak forcemeasurement after the therapeutic device has been removed, which iscontrasted with the peak force when a therapeutic device is beingapplied to a patient. Additionally, the threshold represents ameaningful change in force, based upon published literature. As shown inFIG. 12, a significant difference was observed in the mean EMG Root MeanSquare for the three test conditions between Chip Applied and Post“Treatment” for experimental Subjects (p<0.05). As shown in FIG. 13, areasonable linear relationship was observed for peak force and mean EMGRoot Mean Square (RMS) for the three test conditions. FIG. 14 providesan example of the relationship between the peak force and the mean EMGRoot Mean Square (RMS) for the three test conditions in a singleexperimental subject, anterior deltoid muscle.

In other embodiments of the invention, an additional layer or layerscomprise a resonance frequency or resonance frequencies that are used inapplications of the device 32. In these embodiments, the additionallayer or layers and its resonance frequency or frequencies may beutilized in tandem with the device and its resonance frequency orfrequencies, or the additional layer or layers may stand alone. In otherwords, the device 32 may optionally include additional layer or layersalong with a delivery mechanism to generate the therapeutic benefits ofthe invention.

The size and shape of a carrier layer at least partially determines theresonance frequency of the carrier layer, and the range of frequenciesthat the carrier layer is capable of generating. For example, when thecarrier layer is a crystal, the crystal may comprise a particular cutthat influences the crystal's resonance frequency as well as howenvironmental qualities such as temperature, pressure, and humidityimpact the performance of the crystal. Examples of crystal cuts include,but are not limited to, AT, SC, BT, IT, FC, AK, CT, DT, SL, GT, E, 5° X,MT, ET, FT, NT, XY, H, J, RT, SBTC, TS, X 30°, LC, AC, BC, NLSC, Y, X,and combinations thereof.

The material that the carrier layer is made from also at least partiallydetermines the resonance frequency of the carrier layer, and the rangeof frequencies that the carrier layer is capable of generating. Thecarrier layer may be comprised of a variety of materials including, butnot limited to, piezoelectric crystal, quartz, silicon, plastic, glass,saline solution, mineral solution, synthetic crystal, sapphire,moissanite, natural crystal, gem stone, metal, ceramic, resin, viscoussubstance, lithium tantalate, lithium niobate, lithium borate,berlinite, gallium arsenide, lithium tetraborate, aluminium phosphate,bismuth germanium oxide, polycrystalline zirconium titanate ceramics,high-alumina ceramics, silicon-zinc oxide composite, dipotassiumtartrate, gallium phosphate, langasite, langanite, langanate, leadedglass comprising 18 to 40% lead oxide determined on a weight basis, anddoped variants and/or combinations thereof.

In some embodiments of the present invention the additional layer orlayers are resonance inert, meaning the layer does not comprise aresonance frequency. These layers may simply provide a substrate forother imprinted layers. For example, a silicon wafer grown by theCzochralski method adds no characteristic resonance frequencies beyondits natural phonon frequencies.

Delivery mechanisms that excite frequency responses via sympatheticresonance utilize electromagnetic or mechanical waves.

Although the present disclosure describes components and functionsimplemented in the aspects, embodiments, and/or configurations withreference to particular standards and protocols, the aspects,embodiments, and/or configurations are not limited to such standards andprotocols. Other similar standards and protocols not mentioned hereinare in existence and are considered to be included in the presentdisclosure.

The present disclosure, in various aspects, embodiments, and/orconfigurations, includes components, methods, processes, systems and/orapparatus substantially as depicted and described herein, includingvarious aspects, embodiments, configurations embodiments,sub-combinations, and/or subsets thereof. Those of skill in the art willunderstand how to make and use the disclosed aspects, embodiments,and/or configurations after understanding the present disclosure. Thepresent disclosure, in various aspects, embodiments, and/orconfigurations, includes providing devices and processes in the absenceof items not depicted and/or described herein or in various aspects,embodiments, and/or configurations hereof, including in the absence ofsuch items as may have been used in previous devices or processes, e.g.,for improving performance, achieving ease and\or reducing cost ofimplementation.

The foregoing discussion has been presented for purposes of illustrationand description. The foregoing is not intended to limit the disclosureto the form or forms disclosed herein. In the foregoing DetailedDescription for example, various features of the disclosure are groupedtogether in one or more aspects, embodiments, and/or configurations forthe purpose of streamlining the disclosure. The features of the aspects,embodiments, and/or configurations of the disclosure may be combined inalternate aspects, embodiments, and/or configurations other than thosediscussed above. This method of disclosure is not to be interpreted asreflecting an intention that the claims require more features than areexpressly recited in each claim. Rather, as the following claimsreflect, inventive aspects lie in less than all features of a singleforegoing disclosed aspect, embodiment, and/or configuration. Thus, thefollowing claims are hereby incorporated into this Detailed Description,with each claim standing on its own as a separate preferred embodimentof the disclosure.

Moreover, though the description has included description of one or moreaspects, embodiments, and/or configurations and certain variations andmodifications, other variations, combinations, and modifications arewithin the scope of the disclosure, e.g., as may be within the skill andknowledge of those in the art, after understanding the presentdisclosure. It is intended to obtain rights which include alternativeaspects, embodiments, and/or configurations to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

What is claimed is:
 1. A method of delivering replicated key frequenciesof a resonant frequency pattern and delivering a pulsed electromagneticfield frequency to a patient, comprising: providing a formula samplehaving a resonant frequency pattern; identifying a frequency-basedcharacteristic of the resonant frequency pattern of the formula sample;selecting a plurality of key frequencies from the frequency-basedcharacteristic of the resonant frequency pattern for replication;providing an arbitrary waveform generator, a nonlinear element, and atransmitter; generating, by the arbitrary waveform generator, thereplicated key frequencies of the resonant frequency pattern of theformula sample; combining, by the nonlinear element, the replicated keyfrequencies of the resonant frequency pattern of the formula sample anda pulsed electromagnetic field frequency into a mixed electronic signal;and delivering, by the transmitter, the mixed electronic signal to apatient.
 2. The method, as claimed in claim 1, wherein: thefrequency-based characteristic of the resonant frequency pattern of theformula sample is a nuclear magnetic resonance spectrum of the formulasample, wherein the nuclear magnetic resonance spectrum has a pluralityof local peaks, and at least one of the local peaks are selected as keyfrequencies of the resonant frequency pattern of the formula sample. 3.The method, as claimed in claim 1, wherein: the frequency-basedcharacteristic of the resonant frequency pattern of the formula sampleis an infrared vibrational spectrum of the formula sample, wherein theinfrared vibrational spectrum has a plurality of local peaks that havebeen frequency-shifted down to frequencies with harmonics at theinfrared frequencies, and at least one of the local peaks are selectedas key frequencies of the resonant frequency pattern of the formulasample.
 4. The method as claimed in claim 1, wherein: the mixedelectronic signal combined by the nonlinear element comprises awaveform, wherein the waveform is one or more of a square wave, a pulsewave, and a sawtooth wave.
 5. The method as claimed in claim 1, wherein:the nonlinear element is a diode configured to combine the keyfrequencies and sum and difference frequencies of the key frequencieswith the pulsed electromagnetic field frequency into the mixedelectronic signal.
 6. The method as claimed in claim 1, wherein: apulsed electromagnetic field device comprises the arbitrary waveformgenerator and the nonlinear element, and the mixed electronic signal isa pulsed electromagnetic field output that is modulated by thereplicated key frequencies of the resonant frequency pattern of theformula sample.
 7. A method of delivering replicated key frequencies ofa resonant frequency pattern to a patient to catalyze a response of thepatient to a therapy, comprising: providing a formula sample having aresonant frequency pattern; identifying a frequency-based characteristicof the resonant frequency pattern of the formula sample; selecting aplurality of key frequencies from the frequency-based characteristic ofthe resonant frequency pattern for replication; providing an arbitrarywaveform generator and a transmitter; delivering, by the transmitter,the replicated key frequencies of the resonant frequency pattern of theformula sample that are generated by the arbitrary waveform generator toa patient; and applying a therapy to the patient, wherein the deliveryof the replicated key frequencies of the formula sample to the patientcatalyzes a response of the patient to the therapy.
 8. The method, asclaimed in claim 7, wherein: the frequency-based characteristic of theresonant frequency pattern of the formula sample is a nuclear magneticresonance spectrum of the formula sample, wherein the nuclear magneticresonance spectrum has a plurality of local peaks, and at least one ofthe local peaks are selected as key frequencies of the resonantfrequency pattern of the formula sample.
 9. The method, as claimed inclaim 7, wherein: the frequency-based characteristic of the resonantfrequency pattern of the formula sample is an infrared vibrationalspectrum of the formula sample that has been frequency-shifted down tofrequencies with harmonics at the infrared frequencies, wherein theinfrared vibrational spectrum has a plurality of local peaks, and atleast one of the local peaks are selected as key frequencies of theresonant frequency pattern of the formula sample.
 10. The method asclaimed in claim 7, wherein: the replicated key frequencies of theresonant frequency pattern of the formula sample generated by thearbitrary waveform generator comprise a waveform, wherein the waveformis one or more of a square wave, a pulse wave, and a sawtooth wave. 11.The method as claimed in claim 7, wherein: the formula sample is acomposite formula that comprises at least one resonant frequency patternfrom at least one of a nutraceutical formula, an oxygen formula, and ahypoxic formula.
 12. The method as claimed in claim 7, wherein: thetherapy applied to the patient is an electromagnetic therapy, which hasa pulsed electromagnetic field device that delivers a pulsedelectromagnetic field to the patient, and the pulsed electromagneticfield and the replicated key frequencies of the formula sample aresimultaneously delivered to the patient.
 13. The method as claimed inclaim 7, wherein: the therapy applied to the patient is anon-electromagnetic therapy, which is one of a pharmaceutical compound,a physical and chiropractic therapy, a homeopathy therapy, anacupuncture therapy, psychological counseling, Qigong medicine, andAyurvedic medicine.
 14. The method as claimed in claim 7, wherein: thetherapy applied to the patient is a non-electromagnetic therapy,comprising: positioning a muscle tissue of the patient having apotential imbalance in a state of contraction; confirming an indicatorchange in the muscle; delivering the replicated key frequencies to thepatient; again placing the muscle in a state of contraction; applyingpressure to the muscle; and retesting the muscle to confirm atherapeutic effect has been achieved.
 15. A method of deliveringreplicated key frequencies of a resonant frequency pattern to a patientto catalyze a response of the patient to a therapy, comprising:providing a formula sample having a resonant frequency pattern;identifying a frequency-based characteristic of the resonant frequencypattern of the formula sample; selecting a plurality of key frequenciesfrom the frequency-based characteristic of the resonant frequencypattern for replication; imprinting a device with the replicated keyfrequencies of the resonant frequency pattern of the formula sample;placing the imprinted device proximate to a patient; and applying atherapy to the patient, wherein the replicated key frequencies of theformula sample from the imprinted device catalyzes a response of thepatient to the therapy.
 16. The method as claimed in claim 15, wherein:the frequency-based characteristic of the resonant frequency pattern ofthe formula sample is a nuclear magnetic resonance spectrum of theformula sample, wherein the nuclear magnetic resonance spectrum has aplurality of local peaks, and at least one of the local peaks areselected as key frequencies of the resonant frequency pattern of theformula sample.
 17. The method, as claimed in claim 15, wherein: thefrequency-based characteristic of the resonant frequency pattern of theformula sample is an infrared vibrational spectrum of the formulasample, wherein the infrared vibrational spectrum has a plurality oflocal peaks that have been frequency-shifted down to frequencies withharmonics at the infrared frequencies, and at least one of the localpeaks are selected as key frequencies of the resonant frequency patternof the formula sample.
 18. The method, as claimed in claim 15, wherein:the therapy applied to the patient is an electromagnetic therapy, whichhas a pulsed electromagnetic field device that delivers a pulsedelectromagnetic field to the patient, and the pulsed electromagneticfield and the replicated key frequencies of the formula sample aresimultaneously delivered to the patient.
 19. The method, as claimed inclaim 15, wherein: the therapy applied to the patient is anon-electromagnetic therapy, which is one of a pharmaceutical compound,a physical and chiropractic therapy, a homeopathy therapy, anacupuncture therapy, psychological counseling, Qigong medicine, andAyurvedic medicine.
 20. The method, as claimed in claim 15, wherein: aplasma generator imprints the device with the plurality of keyfrequencies from the resonant frequency pattern of the formula sample,the plasma generator comprises a vessel that defines an enclosed volume,and the plasma generator strikes an inert gas in the enclosed volumeinto a plasma state, which imprints the device with the plurality of keyfrequencies.